Label: CC SCREEN 100% MINERAL CC CREAM BROAD SPECTRUM SPF 50 426W- titanium dioxide, zinc oxide cream
- NDC Code(s): 75936-239-01
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
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 July 10, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply generously and evenly 15 minutes before sun exposure
- reapply at least 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 your time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
•children under 6 months of age: ask a doctor.
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INACTIVE INGREDIENT
Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Iron Oxides, Butyloctyl Salicylate, Isododecane, Propanediol, Glycerin, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Dimethicone, 1,2-Hexanediol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Yellow 5 Lakes, Silica, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica, Hydroxyacetophenone, Diethylhexyl Syringlidenemalonate, Titanium Dioxide, Trisodium Ethylenediamine Disuccinate, Chlorphenesin, Xanthan Gum, Chrondrus Crispus Extract, Caprylic/Capric Triglyceride, Tin Oxide, Sodium Hyaluronate, Tocopherol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CC SCREEN 100% MINERAL CC CREAM BROAD SPECTRUM SPF 50 426W
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-239 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) GLYCERIN (UNII: PDC6A3C0OX) .BETA.-TOCOPHEROL (UNII: 9U6A490501) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) PROPANEDIOL (UNII: 5965N8W85T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) APPLE (UNII: B423VGH5S9) SODIUM CHLORIDE (UNII: 451W47IQ8X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STANNIC OXIDE (UNII: KM7N50LOS6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-239-01 47 mL in 1 CARTON; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/21/2020 Labeler - Supergoop, LLC (117061743)
