Label: COMPLETE BEAUTY- octinoxate and zinc oxide lotion 

  • Label RSS
  • NDC Code(s): 41190-503-26
  • Packager: Wakefern Food Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • Extra back panel claims

    Complete

    beauty lotion

    all day moisturizer

    Broad Sptctrum SPF 15

    Sunscreen

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  • Active ingredients

    Active ingredients

    Octinoxate 6.0%

    Zinc Oxide 3.0%

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  • Purpose

    Purpose

    Sunscreen

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  • Use

    Uses

    • helps prevent sunbrun
    • 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
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  • Warnings

    Warnings

    For external use only

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  • Do not use

    Do not use on damaged or broken skin

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  • When using this product

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

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  • Stop use

    Stop use and ask a doctor if rash occurs

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  • Keep out of reach of children

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

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  • Directions

    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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protections measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-fleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
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  • other information

    Other information

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

    Inactive ingredients water, glycerin, isohexadecan, polysorbate 80, sodium acrylate/acryloyldimethyl taurate copolymer, laureth-7, cyclopentasiloxane, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, gossypium herbaceum (cotton) seen oil, behenyl alcohol, tocopheryl acetate, cetyl alcohol, DMDM hydantoin, itodpropynyl butylcarbamate, steareth-2, disodium EDTA, aloe barbadensis leaf extract, oleth-3 phosphate

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  • Side Panel Claims

    Broad spectrum SPF 15

    Sunscreen

    with vitaming E and aloe

    Sensitive Skin

    light and non-greasy lotion

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  • Disclaimer

    This product is not manufactured or distributed by Procter + Gamble, distributer or Olay Complete All Day Moisture Lotion SPF 15

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  • Adverse Reactions Section

    DISTRIBUTED BY

    WAKEFERN FOOD CORPORATION

    5000 RIVERSIDE DRIVE,

    KEASBEY, NJ O8832

    1-800-SHOPRITE

    www.shoprite.com

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  • principal display panel

    Compare to Olay Complete All Day Moisture Lotion SPF 15

    complete

    beauty

    lotion

    all day

    moisturizer

    Broad Spectrum SPF 15

    Sunscreen

    with vitamin E and aloe

    Sensitive Skin

    light and non-greasy lotion

    ShopRite

    4 FL OZ (118 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    COMPLETE BEAUTY 
    octinoxate, zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41190-503
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 60 mg  in 1 mL
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    ISOHEXADECANE  
    POLYSORBATE 80  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)  
    LAURETH-7  
    CYCLOMETHICONE 5  
    PEG/PPG-20/20 DIMETHICONE  
    STEARETH-21  
    STEARYL ALCOHOL  
    LEVANT COTTONSEED OIL  
    DOCOSANOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    CETYL ALCOHOL  
    DMDM HYDANTOIN  
    IODOPROPYNYL BUTYLCARBAMATE  
    STEARETH-2  
    EDETATE DISODIUM  
    ALOE VERA LEAF  
    OLETH-3 PHOSPHATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41190-503-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 01/09/2013
    Labeler - Wakefern Food Corporation (069722418)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(41190-503)
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