Label: CC CREAM BROAD SPECTRUM SUNSCREEN SPF 35 FAIR TO LIGHT- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-202-01, 75936-202-02 - Packager: TAYLOR JAMES LTD
- 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 November 12, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
· Apply liberally 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 broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
· wear long-sleeve shirts, pants, hats, and sunglasses· Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Isododecane, Glycerin, Propanediol, Cetyl Diglyceryl, Tris(Trimethylsiloxy)Silyethyl Dimethicone, 1-2-Hexandiol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Iron Oxides, Triethoxycaprylylsilane, Mica, Hydroxyacetophenone, Silica, Titanium Dioxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Trisodium Ethylenediamine Disuccinate, Chlorphenesin, Tin Oxide, Tocopherol, Chondrus Crispus Extract, Sodium Hyaluronate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CC CREAM BROAD SPECTRUM SUNSCREEN SPF 35 FAIR TO LIGHT
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISODODECANE (UNII: A8289P68Y2) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) APPLE (UNII: B423VGH5S9) SODIUM CHLORIDE (UNII: 451W47IQ8X) MICA (UNII: V8A1AW0880) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) CHLORPHENESIN (UNII: I670DAL4SZ) STANNIC OXIDE (UNII: KM7N50LOS6) TOCOPHEROL (UNII: R0ZB2556P8) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-202-02 1 in 1 BOX 05/24/2018 1 NDC:75936-202-01 47 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/11/2018 Labeler - TAYLOR JAMES LTD (033381850) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 052400223 manufacture(75936-202)
