Label: 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
- NDC Code(s): 82575-300-01, 82575-301-01
- Packager: Curology
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- WARNINGS
-
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
-
INACTIVE INGREDIENT
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.
- QUESTIONS
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SILKSCREEN SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - LIGHT/MEDIUM SHADE
sheer tint mineral sunscreen broad spectrum 50 - light/medium shade lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82575-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.35 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.37 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82575-300-01 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 final M020 07/15/2023 SILKSCREEN SHEER TINT MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 - MEDIUM/DEEP SHADE
sheer tint mineral sunscreen broad spectrum 50 - medium/deep shade lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82575-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.35 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.37 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82575-301-01 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 final M020 07/15/2023 Labeler - Curology (104103284)
