Label: NATURAL SPF 30- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 December 22, 2022

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  • Active Ingredients

    Titanium Dioxide 7.2%

  • Purpose

    Sunscreen

  • Warnings

    Warnings When using this product

    • keep out of the eye area
    • rinse with water to remove
    • stop use and ask a doctor if rash or irritation develops
    • for external use onlyl
    • keep out of reach of children
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Directions: for sunscreen use
    ● apply generously 15 minutes before sun exposure
    ● apply to all skin exposed to the sun
    ● children under 6 months of age: Ask a doctor

  • DOSAGE & ADMINISTRATION

    Directions: for sunscreen use
    ● apply generously 15 minutes before sun exposure
    ● apply to all skin exposed to the sun
    ● children under 6 months of age: Ask a doctor

  • Inactive Ingredients

    Inactive Ingredients:

    isopropyl palmitate, coconut alkanes, coco caprylate/caprate, caprylic/capric triglyceride, stearic acid, alumina, polyhydroxystearic acid, heptyl undecylenate, oryza sativa (rice) bran extract, rosarinus officnailis (rosemary) extract, helianthus annuus (sunflower) seed oil, tocopherol, argania spinosa kernel oil, tocopheryl acetate (vitamin E), bisabolol, squalane

  • Principal Display Panel

    NaturalSPF30

  • INGREDIENTS AND APPEARANCE
    NATURAL SPF 30 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE750 mg  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SQUALANE (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-8304-1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02005/04/2017
    Labeler - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-8304)
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