Label: BEAUTY HYDRATING- octinoxate, zinc oxide lotion

  • NDC Code(s): 75981-909-30
  • Packager: Geiss, Destin + Dunn, Inc
  • 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 September 29, 2022

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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 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

    • 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 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, tocohperyl acetate, disodium EDTA, steareth-2, oleth-3 phosphate, ascorbic acid, panthenol

  • SPL UNCLASSIFIED SECTION

    Complete

    Oil of Beauty Sunscreen Moisture Lotion

    100% Aminobenzoic Acid (PABA)-Free

    Dermatologist Tested

    Light, Non-Greasy Formula

    Non-Comedogenic (Won't Clog Pores)

    Broad-spectrum UVA and UVB Protection with SPF 15 to help prevent premature skin damage.

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

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Olay Complete

    DISTRIBUTED BY:

    Geiss, Destin, & Dunn, Inc.

    Peachtree City, GA 30269

    www. valuelabels.com

    1-866-696-0957

  • principal display panel

    GoodSense

    Complete Oil of Beauty Sunscreen Moisture Lotion

    SPF 15

    Broad-spectrum UVA and UVB protection with SPF 15 to help precent premature

    skin damage

    Compare to active ingredients of Olay Complete

    100% SATISFACTION GUARANTEED

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    BEAUTY HYDRATING 
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-909
    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:75981-909-301 in 1 PACKAGE11/08/2006
    1177 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 finalpart35211/08/2006
    Labeler - Geiss, Destin + Dunn, Inc (076059836)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(75981-909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(75981-909)
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