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 
Autumn Harp

----------

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

Active Ingredient

Zinc Oxide 13.3%

Titanium Dioxide 2.3%

Sunscreen

Helps prevent sunburn

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

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:

Children under 6 months of age: Ask a doctor

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

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

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).

888-859-1188

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:

Children under 6 months of age: Ask a doctor

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

Primary Bottle AWMedium Deep Carton AWLight Medium Carton AWimage components

SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - LIGHT/MEDIUM SHADE 
spf 50 sunscreen broad spectrum - light/medium shade lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0361
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.37 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.35 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0361-146 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/15/2023
SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - MEDIUM/DEEP SHADE 
spf 50 sunscreen broad spectrum - medium/deep shade lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0362
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.37 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.35 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0362-146 g in 1 BOTTLE; Type 0: Not a Combination Product07/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/15/2023
Labeler - Autumn Harp (064187883)

Revised: 6/2023
Document Id: fd6807e1-c8c1-b361-e053-6294a90aea0c
Set id: fd6807e1-c8c0-b361-e053-6294a90aea0c
Version: 1
Effective Time: 20230605
 
Autumn Harp