Label: POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N- homosalate, titanium dioxide, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N- homosalate, titanium dioxide, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N- homosalate, titanium dioxide, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N- homosalate, titanium dioxide, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C- homosalate, titanium dioxide, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W- homosalate, titanium dioxide, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N- homosalate, titanium dioxide, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W- homosalate, titanium dioxide, zinc oxide lotion

  • NDC Code(s): 82109-116-01, 82109-117-01, 82109-118-01, 82109-119-01, view more
    82109-120-01, 82109-121-01, 82109-122-01, 82109-123-01
  • Packager: Rare Beauty, LLC
  • 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 October 17, 2022

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

  • Drug Facts

  • Active ingredients

    Homosalate 9.0%

    Titanium Dioxide 1.8%

    Zinc Oxide 0.9%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    For external use only.

    Do not use

    on damaged or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use if irritation occurs

    and ask a doctor if a rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help right away.

  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Children under 6 months of age: 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
  • Inactive Ingredients

    Water/Aqua, Dimethicone, Talc, C12-15 Alkyl Benzoate, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Isopentyldiol, Sorbitol, Tocopheryl Acetate, Phenoxyethanol, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Sulfate, Sodium Dehydroacetate, Hydrogen Dimethicone, Potassium Sorbate, Disteardimonium Hectorite, Lecithin, Benzoic Acid, Aluminum Hydroxide, Alumina, Dehydroacetic Acid, Propylene Carbonate, Helianthus Annuus (Sunflower) Seed Oil, Triethoxycaprylylsilane, Tocopherol, Ethylhexylglycerin, Ascorbyl Palmitate, Citric Acid, Gardenia Florida Fruit Extract, Nelumbo Nucifera Flower Extract, Nymphaea Odorata Root Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • Questions?

    Call 1-888-892-7273

    Monday-Friday, 7am-4pm PST

  • Company Information

    Dist. By Rare Beauty, LLC

    El Segundo, CA 90245

    Made in Italy

    www.rarebeauty.com

  • 44N

    1

    44N

  • 46C

    46C

    1

  • 48W

    48W

    1

  • 50N

    50N

    1

  • 52W

    52W

    1

  • 54N

    54N

    1

  • 56N

    56N

    1

  • 58N

    58N

    1

  • INGREDIENTS AND APPEARANCE
    POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N 
    homosalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82109-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82109-121-011 in 1 CARTON03/30/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2022
    POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N 
    homosalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82109-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82109-122-011 in 1 CARTON03/30/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2022
    POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N 
    homosalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82109-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82109-123-011 in 1 CARTON03/30/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2022
    POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N 
    homosalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82109-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82109-116-011 in 1 CARTON03/30/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2022
    POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C 
    homosalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82109-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82109-117-011 in 1 CARTON03/30/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2022
    POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W 
    homosalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82109-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82109-118-011 in 1 CARTON03/30/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2022
    POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N 
    homosalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82109-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82109-119-011 in 1 CARTON03/30/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2022
    POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W 
    homosalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82109-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    NYMPHAEA ODORATA ROOT (UNII: 69RAZ4C432)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82109-120-011 in 1 CARTON03/30/2022
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2022
    Labeler - Rare Beauty, LLC (117041437)