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
  • Marketing Status: OTC monograph not 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 October 12, 2022

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    50ml label

    Active ingredients

    Octisalate (Ethylhexyl Salicylate) 5%

    Zinc Oxide 11.6%

    Purpose

    Sunscreen

    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

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Warnings

    For external use only

    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

    Other information

    • protect the product in this container from excessive heat and direct sun

    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 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70809-1912
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION11.6 mg  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70809-1912-115 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2022
    2NDC:70809-1912-21 in 1 BOX04/01/2022
    250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2022
    Labeler - USRX LLC (115270633)
    Registrant - USRX LLC (115270633)