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 liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 14S FAIR-LIGHT SAND- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 15N FAIR-LIGHT NEUTRAL- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 22N LIGHT NEUTRAL- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 22S LIGHT SAND- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 22H LIGHT HONEY- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 22G LIGHT GOLDEN- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 27S LIGHT-MEDIUM SAND- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 27B LIGHT-MEDIUM BEIGE- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 27H LIGHT-MEDIUM HONEY- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 29N LIGHT-MEDIUM NEUTRAL- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 29G LIGHT-MEDIUM GOLDEN- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 32S MEDIUM SAND- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 32H MEDIUM HONEY- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 32N MEDIUM NEUTRAL- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 32G MEDIUM GOLDEN- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 37S MEDIUM-TAN SAND- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 39G MEDIUM-TAN GOLDEN- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 42N TAN NEUTRAL- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 42S TAN SAND- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 46S TAN-DEEP SAND- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 48G TAN-DEEP GOLDEN- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 51H DEEP HONEY- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 51S DEEP SAND- titanium dioxide and zinc oxide liquid 
RAINFOREST OF THE SEA WATER FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 53G DEEP GOLDEN- titanium dioxide and zinc oxide liquid 
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

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.

----------

Rainforest of the Sea™ water foundation Broad Spectrum SPF 15 Sunscreen

Drug Facts

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

Uses

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

Other information

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.

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
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)

Revised: 12/2018
Document Id: 7b04ba82-62e3-4140-8bda-c289bcef50f3
Set id: 6c62c134-8265-44e3-ab08-a5fd021bd562
Version: 1
Effective Time: 20181211
 
Tarte, Inc