Label: CC SCREEN 100% MINERAL CC CREAM BROAD SPECTRUM SPF 50 226W- titanium dioxide, zinc oxide cream
- NDC Code(s): 75936-228-01
- Packager: Supergoop, LLC
- 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 July 10, 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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Apply generously and evenly 15 minutes before sun exposure
Use a water-resistant sunscreen if swimming or sweating
Reapply at least every 2 hours.
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.
-
INACTIVE INGREDIENT
Inactive Ingredients
Water, C12-15 Alkyl Benzonate, Butyoctyl Salicylate, Isododecane, Propanediol, Glycerin, Cetyl Diglyceryl Tris(Trimethylsiloxy) siloxysilylethyl Dimethicone, Iron Oxides, 1,2-Hexanediol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Silica, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydroxyacetophenone, Diethylhexyl Syringylidenemalonate, Mica, Titanium Dioxide, Trisodium Ethylenediamine Disucinate, Chlorphenesin, Xanthan Gum, Chondrus Crispus Extract, Caprylic/Capric Triglyceride, Tin Oxide, Sodium Hyaluronate, Tocopherol
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CC SCREEN 100% MINERAL CC CREAM BROAD SPECTRUM SPF 50 226W
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-228 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISODODECANE (UNII: A8289P68Y2) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STANNIC OXIDE (UNII: KM7N50LOS6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPANEDIOL (UNII: 5965N8W85T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) APPLE (UNII: B423VGH5S9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-228-01 47 mL in 1 TUBE; 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 05/28/2020 Labeler - Supergoop, LLC (117061743)
