Label: POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 36C- homosalate, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 28C- homosalate, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 30N- homosalate, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 40N- homosalate, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 32N- homosalate, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 38N- homosalate, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 34W- homosalate, zinc oxide lotion
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 42N- homosalate, zinc oxide lotion
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NDC Code(s):
82109-132-01,
82109-133-01,
82109-134-01,
82109-135-01, view more82109-136-01, 82109-137-01, 82109-138-01, 82109-139-01
- Packager: Rare Beauty, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 14, 2024
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
- Other Information
-
Inactive Ingredients
Water, Dimethicone, Talc, Isododecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Isopentyldiol, Sorbitol, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Phenoxyethanol, Magnesium Sulfate, Sodium Dehydroacetate, Benzoic Acid, Hydrogen Dimethicone, Triethoxycaprylylsilane, Disteardimonium Hectorite, Potassium Sorbate, Aluminum Hydroxide, Dehydroacetic Acid, Lecithin, Propylene Carbonate, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Ascorbyl Palmitate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Citric Acid, Gardenia Florida Fruit Extract, Nelumbo Nucifera Flower Extract, Nymphaea Odorata Root Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
- Questions?
- Company Information
- 28C
- 30N
- 32N
- 34W
- 36C
- 38N
- 40N
- 42N
-
INGREDIENTS AND APPEARANCE
POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 36C
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-136 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 57 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-136-01 1 in 1 CARTON 11/01/2024 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 Drug M020 11/01/2024 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 28C
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 57 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-132-01 1 in 1 CARTON 11/01/2024 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 Drug M020 11/01/2024 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 30N
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 57 mg in 1 mL Inactive Ingredients Ingredient Name Strength .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) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SORBITOL (UNII: 506T60A25R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-133-01 1 in 1 CARTON 11/01/2024 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 Drug M020 11/01/2024 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 40N
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-138 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 57 mg in 1 mL Inactive Ingredients Ingredient Name Strength PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SORBITOL (UNII: 506T60A25R) ISOPENTYLDIOL (UNII: 19NOL5474Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) SODIUM CHLORIDE (UNII: 451W47IQ8X) 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-138-01 1 in 1 CARTON 11/01/2024 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 Drug M020 11/01/2024 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 32N
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-134 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 57 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-134-01 1 in 1 CARTON 11/01/2024 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 Drug M020 11/01/2024 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 38N
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-137 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 57 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-137-01 1 in 1 CARTON 11/01/2024 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 Drug M020 11/01/2024 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 34W
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-135 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 57 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-135-01 1 in 1 CARTON 11/01/2024 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 Drug M020 11/01/2024 POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 42N
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82109-139 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 65 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 57 mg in 1 mL Inactive Ingredients Ingredient Name Strength PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SORBITOL (UNII: 506T60A25R) ISOPENTYLDIOL (UNII: 19NOL5474Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) SODIUM CHLORIDE (UNII: 451W47IQ8X) 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) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) BENZOIC ACID (UNII: 8SKN0B0MIM) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82109-139-01 1 in 1 CARTON 11/01/2024 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 Drug M020 11/01/2024 Labeler - Rare Beauty, LLC (117041437)
