Label: COMPLETE BEAUTY- octinoxate, zinc oxide lotion

  • NDC Code(s): 72288-503-30
  • Packager: Amazon.com Services LLC
  • 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 July 26, 2023

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  • Claims

    SOLIMO

    Beauty Lotion

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    MOISTURIZER

    SPF 15

  • Active ingredient

    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 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, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, PEG/PPG-20/20 dimethicone, steareth-21, stearyl alcohol, Gossypium herbaceum (cotton) seed oil, behenyl alcohol, tocopheryl acetate, cetyl alcohol, steareth-2, disodium EDTA, Aloe barbadensis leaf extract, oleth-3 phosphate, benzyl alcohol, chlorphenesin

  • side panel claims

    Beauty Lotion

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    MOISTURIZER

    SPF 15

  • Adverse Reactions

    DISTRIBUTED BY:

    Amazon.com Services, LLC

    Seattle, WA 98109  1-877-485-0385

    2018 Amazon.com, Inc. or its affiliates.

    All rights reserved.  Solimo and all related logos are trademarks of Amazon.com, Inc. or its affiliates.

    503.002/503AB

  • principal display panel

    SOLIMO

    Beauty Lotion

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    Sensitive skin

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    COMPLETE BEAUTY 
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 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)  
    PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    COTTONSEED OIL (UNII: H3E878020N)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-2 (UNII: V56DFE46J5)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-503-301 in 1 CARTON04/25/2018
    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 finalpart35204/25/2018
    Labeler - Amazon.com Services LLC (128990418)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72288-503)
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