Label: STATE-48 SUNCARE MINERAL SPF-30- zinc oxide, octisalate, octocrylene cream
- NDC Code(s): 81200-109-00
- Packager: State 48 Suncare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings:
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Directions:
- Apply liberally 15 minutes before sun exposure.
- Children under 6 months of age:ask a doctor
- Reapply at least every 2 hours.
- Reapply as needed or after towel drying swimming or sweating.
- Use a ater-resistant sunscreen if swimming or sweating.
- 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: Sun Protection Measures.
- Limit time in the sun, especially from 10a.m. - 2.p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
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Inactive Ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Bixa Orellana (Annatto) Extract, Butylcotyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Chamomilla Recutita (Chamomile) Extract, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower)Oil, Hydroxyethylcellulose, Leuconostoc/Radih Root Ferment Filtrate, Mangifera Indica (Mango) Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.
- Other Information
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
STATE-48 SUNCARE MINERAL SPF-30
zinc oxide, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81200-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 60 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARGAN OIL (UNII: 4V59G5UW9X) BIXA ORELLANA SEED (UNII: O87354RZ5A) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CHAMOMILE (UNII: FGL3685T2X) CARROT (UNII: L56Z1JK48B) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DODECANE (UNII: 11A386X1QH) ETHYL VANILLIN (UNII: YC9ST449YJ) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MANGO (UNII: I629I3NR86) AVOCADO OIL (UNII: 6VNO72PFC1) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) CORN (UNII: 0N8672707O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81200-109-00 177 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/01/2020 Labeler - State 48 Suncare LLC (120989740)
