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

44N

46C

48W

50N

52W

54N

56N

58N

POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N
homosalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82109-121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2022

POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N
homosalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82109-122
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2022

POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N
homosalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82109-123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2022

POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N
homosalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82109-116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2022

POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C
homosalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82109-117
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2022

POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W
homosalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82109-118
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2022

POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N
homosalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82109-119
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2022

POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W
homosalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82109-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2022

Labeler - Rare Beauty, LLC (117041437)

Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen