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

Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 58N by

Drug Labeling and Warnings

Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 58N by is a Otc medication manufactured, distributed, or labeled by Rare Beauty, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Homosalate 6.5%

Zinc Oxide 5.7%

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

Other Information

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

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?

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

46C

48W

50N

52W

54N

56N

58N

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82109-142
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: 82109-142-01	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 44N 
homosalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82109-140
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82109-140-01	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 46C 
homosalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82109-141
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: 82109-141-01	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 50N 
homosalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82109-143
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: 82109-143-01	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 52W 
homosalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82109-144
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: 82109-144-01	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 54N 
homosalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82109-145
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: 82109-145-01	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 56N 
homosalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82109-146
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: 82109-146-01	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 58N 
homosalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82109-147
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)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82109-147-01	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)