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 more82109-120-01, 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
-
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
- Questions?
- Company Information
- 44N
- 46C
- 48W
- 50N
- 52W
- 54N
- 56N
- 58N
-
INGREDIENTS AND APPEARANCE
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N
homosalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-121-01 1 in 1 CARTON 03/30/2022 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2022 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N
homosalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-122-01 1 in 1 CARTON 03/30/2022 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2022 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N
homosalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-123-01 1 in 1 CARTON 03/30/2022 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2022 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N
homosalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-116-01 1 in 1 CARTON 03/30/2022 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2022 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C
homosalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-117-01 1 in 1 CARTON 03/30/2022 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2022 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W
homosalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-118-01 1 in 1 CARTON 03/30/2022 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2022 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N
homosalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-119-01 1 in 1 CARTON 03/30/2022 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2022 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W
homosalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 18 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-120-01 1 in 1 CARTON 03/30/2022 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2022 Labeler - Rare Beauty, LLC (117041437)
