SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - LIGHT/MEDIUM SHADE- spf 50 sunscreen broad spectrum - light/medium shade lotion SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - MEDIUM/DEEP SHADE- spf 50 sunscreen broad spectrum - medium/deep shade lotion

Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Medium/Deep Shade by

Drug Labeling and Warnings

Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Medium/Deep Shade by is a Otc medication manufactured, distributed, or labeled by Autumn Harp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide 13.3%

Titanium Dioxide 2.3%

PURPOSE

Sunscreen

DOSAGE & ADMINISTRATION

Helps prevent sunburn

WARNINGS

For external use only

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right awy

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

INSTRUCTIONS FOR USE

Apply generously 15 minutes before sun exposure

Reapply every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10am - 2pm,
• Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

OTHER SAFETY INFORMATION

Store at 20-25C (68-77F)

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

INACTIVE INGREDIENT

Caprylic/Capric Triglyceride, Water, Diisopropyl Sebacate, Polymethylsilsesquioxane, Undecane, Aloe Barbadensis Leaf Juice, Glycerin, Polyglyceryl-6 Polyricinoleate, Isododecane, Dimethicone, Mica, Polysilicone-11, Tridecane, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Tocopheryl Acetate, Polyglyceryl-2 Isostearate, Disteardimonium Hectorite, Phenoxyethanol, Dimethicone Crosspolymer, Sodium Chloride, Triethoxycaprylylsilane, Alumina, Propanediol, Iron Oxide (CI 77492), Magnesium Stearate, Jojoba Esters, Disodium EDTA, 1,2-Hexanediol, Bisabolol, Propylene Carbonate, Titanium Dioxide (CI 77891), Niacinamide, Iron Oxides (CI 77491), Cyclohexasiloxane, Laureth-12, Caprylhydroxamic Acid, Iron Oxides (Black, CI 77499), Sodium Hyaluronate, Ethylhexylglycerin, Tocopherol, Glycyrrhiza Glabra (Licorice) Root Extract, Iron Oxides (CI77499).

QUESTIONS

888-859-1188

INDICATIONS & USAGE

Apply generously 15 minutes before sun exposure

Reapply every 2 hours

Use a water resistant sunscreen if swimming or sweating

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 10am - 2pm,
• Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

PRINCIPAL DISPLAY PANEL

image components

INGREDIENTS AND APPEARANCE

SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - LIGHT/MEDIUM SHADE 
spf 50 sunscreen broad spectrum - light/medium shade lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0361
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.37 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.35 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURETH-12 (UNII: OAH19558U1)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
UNDECANE (UNII: JV0QT00NUE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
TRIDECANE (UNII: A3LZF0L939)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPANEDIOL (UNII: 5965N8W85T)
MAGNESIUM STEARATE (UNII: 70097M6I30)
EDETATE DISODIUM (UNII: 7FLD91C86K)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
NIACINAMIDE (UNII: 25X51I8RD4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
DIMETHICONE 100 (UNII: RO266O364U)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0361-1	46 g in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/15/2023

SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - MEDIUM/DEEP SHADE 
spf 50 sunscreen broad spectrum - medium/deep shade lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.37 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.35 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURETH-12 (UNII: OAH19558U1)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
UNDECANE (UNII: JV0QT00NUE)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
TRIDECANE (UNII: A3LZF0L939)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPANEDIOL (UNII: 5965N8W85T)
MAGNESIUM STEARATE (UNII: 70097M6I30)
EDETATE DISODIUM (UNII: 7FLD91C86K)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
NIACINAMIDE (UNII: 25X51I8RD4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
DIMETHICONE 100 (UNII: RO266O364U)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0362-1	46 g in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/15/2023

Labeler - Autumn Harp (064187883)