Label: SUNSCREEN- octinoxate, octisalate, zinc oxide cream

  • 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 March 10, 2022

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

  • claims

    CLEAR ZINC SUNSCREEN

    BROAD SPECTRUM SPF 50

    Dermatologist-Tested • UVA/UVB Protection
    Goes on Clear • With Aloe and Vitamin E

  • active ingredients

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 10%

  • Purpose

    Sunscreen

  • uses

    • helps prevent sunburn
    • if used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

  • 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.

  • directions

    Directions
    ■ apply liberally 15 minutes before sun exposure
    ■ reapply:
    ■ after 80 minutes of swimming or sweating
    ■ immediately after towel drying

    ■ 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 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

  • Other information

    • protect the product from excessive heat and direct sun
  • inactive ingredients

    water, butyloctyl salicylate, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, propanediol, triacontanyl PVP, cetearyl alcohol, PEG-100 stearate, cetearyl glucoside, glyceryl behenate, dimethicone, glycerin, PEG-150/decyl alcohol/SMDI copolymer, Aloe barbadensis leaf juice, allantoin, panthenol, tocopheryl acetate, triethoxycaprylylsilane, fragrance, phenoxyethanol, methylisothiazolinone, tetrasodium EDTA

  • claims

    May stain or damage some fabrics or surfaces 

  • disclaimer

    This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Spray Sport Broad Spectrum SPF 70

    DSP-TN-15000  DSP-MO-34 SDS-TN-15012

    100%

    Satisfaction

    Guaranteed!

    (888)309-9030

  • Adversation reaction

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

  • Principal Display Panel

    STUDIO

    SELECTION SUN

    CLEAR ZINC SUNSCREEN

    BROAD SPECTRUM SPF 50

    • Water-Resistant (80 minutes)
    • For face, nose or ears
    • Paraben Free

    SPF 50

    NET WT 1 OZ (28.3 g)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-726
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE562 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE250 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1000 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1000 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-150/DECYL ALCOHOL/SMDI COPOLYMER (1350 MPA.S AT 3%) (UNII: VP5LS3541F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-726-1028.3 g in 1 PACKAGE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2019
    Labeler - OLD EAST MAIN CO. (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-726)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-726)