Label: RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 8S PORCELAIN- titanium dioxide and zinc oxide liquid
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 12B FAIR BEIGE- titanium dioxide and zinc oxide liquid
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 12N FAIR NEUTRAL (titanium dioxide and zinc oxide) .......ng> RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 57N RICH NEUTRAL (titanium dioxide and zinc oxide) liquid RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 57S RICH SAND (titanium dioxide and zinc oxide) liquid RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 61H MAHOGANY- titanium dioxide and zinc oxide liquid [Tarte, Inc]
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 57N RICH NEUTRAL- titanium dioxide and zinc oxide liquid
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 57S RICH SAND- titanium dioxide and zinc oxide liquid
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 61H MAHOGANY- titanium dioxide and zinc oxide liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    51060-167-01, 51060-168-01, 51060-169-01, 51060-170-01, view more
    51060-171-01, 51060-172-01, 51060-173-01, 51060-174-01, 51060-175-01, 51060-176-01, 51060-177-01, 51060-178-01, 51060-179-01, 51060-180-01, 51060-181-01, 51060-182-01, 51060-183-01, 51060-184-01, 51060-185-01, 51060-186-01, 51060-187-01, 51060-188-01, 51060-189-01, 51060-190-01, 51060-191-01, 51060-192-01, 51060-193-01, 51060-194-01, 51060-195-01, 51060-196-01
  • Packager: Tarte, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 11, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 6.22%Sunscreen
    Zinc Oxide 3.83%Sunscreen
  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only.

    Stop use and ask doctor if rash occurs.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake before use.
    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months: Ask a doctor.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      Limit time in the sun, especially from 10 a.m.-2 p.m.
      Wear long-sleeved shirts, pants, hats and sunglasses
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
    • You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222.
  • Inactive ingredients

    Water, glycerin, isododecane, cyclopentasiloxane, phenyl trimethicone, nylon-12, dipropylene glycol, caprylic/capric triglyceride, alcohol denat., cyclohexasiloxane, butylene glycol, aluminum starch octenylsuccinate, cetyl PEG/PPG-10/1 dimethicone, magnesium sulfate, PEG-9 polydimethylsiloxyethyl dimethicone, alumina, silica, sorbitan isostearate, stearalkonium hectorite, polyglyceryl-4 isostearate, hexyl laurate, stearic acid, aluminum hydroxide, triethoxycaprylylsilane, propylene carbonate, caprylyl glycol, dimethicone, phenoxyethanol, tocopheryl acetate, 1,2-hexanediol, cocos nucifera (coconut) oil, algae extract/sargassum pacificum thallus extract , gardenia taitensis flower extract , tocopherol, iron oxides. EX111FL000421.

  • SPL UNCLASSIFIED SECTION

    Dist. by tarte, Inc. New York, NY
    10018.

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 8S porcelain

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 8S porcelain
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 12B fair beige

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 12B fair beige
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 12N fair neutral

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 12N fair neutral
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 14S fair-light sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 14S fair-light sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 15N fair-light neutral

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 15N fair-light neutral
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 22N light neutral

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 22N light neutral
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 22S light sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 22S light sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 22H light honey

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 22H light honey
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 22G light golden

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 22G light golden
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 27S light-medium sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 27S light-medium sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 27B light-medium beige

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 27B light-medium beige
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 27H light-medium honey

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 27H light-medium honey
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 29N light-medium neutral

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 29N light-medium neutral
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 29G light-medium golden

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 29G light-medium golden
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 32S medium sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 32S medium sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 32H medium honey

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 32H medium honey
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 32N medium neutral

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 32N medium neutral
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 32G medium golden

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 32G medium golden
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 37S medium-tan sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 37S medium-tan sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 39G medium-tan golden

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 39G medium-tan golden
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 42N tan neutral

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 42N tan neutral
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 42S tan sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 42S tan sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 46S tan-deep sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 46S tan-deep sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 48G tan-deep golden

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 48G tan-deep golden
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 51H deep honey

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 51H deep honey
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 51S deep sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 51S deep sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 53G deep golden

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 53G deep golden
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 57N rich neutral

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 57N rich neutral
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 57S rich sand

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 57S rich sand
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 61H mahogany

    tarte
    high-performance naturals™

    RAINFOREST
    OF THE
    Sea™

    water foundation

    Broad Spectrum
    SPF 15 Sunscreen

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 61H mahogany
  • INGREDIENTS AND APPEARANCE
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  8S PORCELAIN
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-167
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-167-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  12B FAIR BEIGE
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-168
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-168-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  12N FAIR NEUTRAL
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-169
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-169-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  14S FAIR-LIGHT SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-170-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  15N FAIR-LIGHT NEUTRAL
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-171
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-171-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  22N LIGHT NEUTRAL
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-172
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-172-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  22S LIGHT SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-173-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  22H LIGHT HONEY
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-174
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-174-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  22G LIGHT GOLDEN
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-175
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-175-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  27S LIGHT-MEDIUM SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-176
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-176-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  27B LIGHT-MEDIUM BEIGE
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-177-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  27H LIGHT-MEDIUM HONEY
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-178
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-178-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  29N LIGHT-MEDIUM NEUTRAL
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-179
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-179-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  29G LIGHT-MEDIUM GOLDEN
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-180-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  32S MEDIUM SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-181
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-181-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  32H MEDIUM HONEY
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-182
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-182-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  32N MEDIUM NEUTRAL
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-183
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-183-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  32G MEDIUM GOLDEN
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-184
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-184-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  37S MEDIUM-TAN SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-185-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  39G MEDIUM-TAN GOLDEN
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-186
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-186-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  42N TAN NEUTRAL
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-187-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  42S TAN SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-188-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  46S TAN-DEEP SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    NYLON-12 (UNII: 446U8J075B)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-189-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  48G TAN-DEEP GOLDEN
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-190-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  51H DEEP HONEY
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-191-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  51S DEEP SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-192
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-192-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  53G DEEP GOLDEN
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-193
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-193-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  57N RICH NEUTRAL
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-194
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-194-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  57S RICH SAND
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-195
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-195-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN  61H MAHOGANY
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-196
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62.2 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-196-011 in 1 CARTON11/01/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    Labeler - Tarte, Inc (027905186)