Label: COMPLETE BEAUTY- octinoxate, zinc oxide lotion

  • 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 May 13, 2020

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  • Active ingredients

    Octinoxate 6.0%

    Zinc oxide 3.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the rise 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

    • 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 highter and other sun protection measures including:
    • limit the 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, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, cyclopentasiloxane, cyclohexasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, Gossypium Herbaceum (cotton) seed oil, behenyl alcohol, cetyl alcohol, DMDM hydantoin, iodopropynyl butylcarbamate, fragrance, tocopheryl acetate, disodium EDTA, steareth-2, oleth-3 phosphate, ascorbic acid, panthenol

  • SPL UNCLASSIFIED SECTION

    Complete Beauty lotion

    100% Ainobenzoic Acid (PABA)-Free

    Dermatologist Tested

    Light, Non-Greast Formula

    Non-Comedogenic (Won't Clog Pores)

    Broad Spectrum SPF 15 Sunscreen

    When used as directed, complete beauty lotion helps provide your skin with broad spectrum protection against prematue skin damage from both UVA and UVB rays to help your skin stay younger looking.

    ALL DAY MOISTURE - Formulated with antioxidant Vitamin E plus C and nourishihg beauty moisture that absorbs quickly into skin and lasts all day to help your skin stay soft, smooth and beautiful.

    DISTRIBUTED BY:

    AMERICAN SALES CO.

    4201 WALDEN AVE

    LANCASTER, NY 14086

    www.care1.info

    2012 S+S Brands, Inc

    Quality Guaranteed or Your Money Back

    909.005/909AE

  • Principal display Panel

    CAREONE

    complete beauty lotion

    UVA and UVB protection plus vitamin E + C

    broad spectrum spf 15 sunscreen

    4.0 fl oz (118 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    COMPLETE BEAUTY 
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-909
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE61.2 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARETH-2 (UNII: V56DFE46J5)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-909-261 in 1 PACKAGE01/13/2010
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/13/2010
    Labeler - American Sales Co (809183973)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(41520-909)
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