SILKSCREEN SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - LIGHT/MEDIUM SHADE- sheer tint mineral sunscreen broad spectrum 50 - light/medium shade lotion 
SILKSCREEN SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - MEDIUM/DEEP SHADE- sheer tint mineral sunscreen broad spectrum 50 - medium/deep shade lotion 
Curology

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active Ingredient

Zinc Oxide 13.3%

Titanium Dioxide 2.3%

Sunscreen

Helps prevent sunburn

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

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

858-859-1188

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.

artwork components Primary Bottle AWLight Medium Carton AWMedium Deep Carton AW

SILKSCREEN SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - LIGHT/MEDIUM SHADE 
sheer tint mineral sunscreen broad spectrum 50 - light/medium shade lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82575-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.35 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.37 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
UNDECANE (UNII: JV0QT00NUE)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TRIDECANE (UNII: A3LZF0L939)  
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
JOJOBA OIL (UNII: 724GKU717M)  
NIACINAMIDE (UNII: 25X51I8RD4)  
WATER (UNII: 059QF0KO0R)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
DIMETHICONE 100 (UNII: RO266O364U)  
PROPANEDIOL (UNII: 5965N8W85T)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
LAURETH-6 (UNII: J2N33740SH)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82575-300-0146 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 finalM02007/15/2023
SILKSCREEN SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - MEDIUM/DEEP SHADE 
sheer tint mineral sunscreen broad spectrum 50 - medium/deep shade lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82575-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.35 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.37 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
UNDECANE (UNII: JV0QT00NUE)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TRIDECANE (UNII: A3LZF0L939)  
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
JOJOBA OIL (UNII: 724GKU717M)  
NIACINAMIDE (UNII: 25X51I8RD4)  
WATER (UNII: 059QF0KO0R)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
DIMETHICONE 100 (UNII: RO266O364U)  
PROPANEDIOL (UNII: 5965N8W85T)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
LAURETH-6 (UNII: J2N33740SH)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82575-301-0146 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 finalM02007/15/2023
Labeler - Curology (104103284)

Revised: 6/2023
Document Id: fda2afaf-3d15-92b3-e053-6394a90a7493
Set id: fda2afaf-3d14-92b3-e053-6394a90a7493
Version: 1
Effective Time: 20230608
 
Curology