Label: COMPLEXION PROTECTION MOISTURIZER SPF- zinc oxide, octisalate cream
- NDC Code(s): 70809-1912-1, 70809-1912-2
- Packager: USRX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
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PRINCIPAL DISPLAY PANEL
Uses
- helps prevent sunburn
- if used as directed with ohter sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Directions
For sunscreen use:
- apply liberally 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 time in the sun, especially from 10 a.m.-2 p.m.
- wear lon-sleeved shirts, pants, hats and sunglasses
- Children under 6 months of age:Ask a doctor
Inactive ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Propanediol, Tetradecane, Butyloctyl Salicylate,
C12-15 Alkyl Benzoate, Polyester-8, Cetearyl Olivate, Glycerin, Lauroyl Lysine, Silica,
Polyhydroxystearic Acid, Glyceryl Stearate Citrate, Niacinamide, Pentylene Glycol,
Potassium Cetyl Phosphate, Sorbitan Olivate, Inulin Lauryl Carbamate, 1,2-Hexanediol,
Hydroxyacetophenone, Squalane, Diethylhexyl Syringylidenemalonate, Cetearyl Alcohol,
Acacia Senegal Gum, Lactic Acid, Xanthan Gum, Sodium Stearoyl Glutamate,
Chlorphenesin, Coco-Glucoside, Trisodium Ethylenediamine Disuccinate, Tocopheryl
Acetate (Vitamin E), Tridecane, Sodium Citrate, C13-14 Allkane, Cucumis Sativus
(Cucumber) Fruit Extract, Sodium Hyaluronate, Ascorbic Acid (Vitamin C) -
INGREDIENTS AND APPEARANCE
COMPLEXION PROTECTION MOISTURIZER SPF
zinc oxide, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70809-1912 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 11.6 mg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 100 mL Inactive Ingredients Ingredient Name Strength INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG) PROPANEDIOL (UNII: 5965N8W85T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) LAUROYL LYSINE (UNII: 113171Q70B) NIACINAMIDE (UNII: 25X51I8RD4) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LACTIC ACID, L- (UNII: F9S9FFU82N) CUCUMBER (UNII: YY7C30VXJT) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) CHLORPHENESIN (UNII: I670DAL4SZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ACACIA (UNII: 5C5403N26O) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) TRIDECANE (UNII: A3LZF0L939) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PENTYLENE GLYCOL (UNII: 50C1307PZG) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R) ASCORBIC ACID (UNII: PQ6CK8PD0R) XANTHAN GUM (UNII: TTV12P4NEE) TETRADECANE (UNII: 03LY784Y58) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) WATER (UNII: 059QF0KO0R) CETEARYL OLIVATE (UNII: 58B69Q84JO) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERIN (UNII: PDC6A3C0OX) SQUALANE (UNII: GW89575KF9) SORBITAN OLIVATE (UNII: MDL271E3GR) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70809-1912-1 15 mL in 1 TUBE; Type 0: Not a Combination Product 04/01/2022 2 NDC:70809-1912-2 1 in 1 BOX 04/01/2022 2 50 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 Drug M020 04/01/2022 Labeler - USRX LLC (115270633) Registrant - USRX LLC (115270633)