Label: NATURAL SPF 50- titanium dioxide, zinc oxide lotion

  • 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 December 22, 2022

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  • Active Ingredients

    Titanium Dioxide 7.2%

    Zinc Oxide 9.5%

  • 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.

  • 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

  • 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

  • Inactive Ingredients

    Inactive Ingredients:

    carthamus tinctorius (safflower) seed oil, coconut alkanes, coco caprylate/caprate, caprylic/capric triglyceride, stearic acid, alumina, polyhydroxystearic acid, helianthus annuus (sunflower) seed oil, pongamia glabra (karanja) seed oil, vitis vinifera (grape) see oil, olea europaea (olive) oil, argania spinosa (argan) oil, oryza sativa (rice) bran extract, rosarinus officnailis (rosemary) extract, tocopherol, argania spinosa kernel oil, tocopheryl acetate (vitamin E), bisabolol, squalane

  • Principal Display Panel

    NaturalSPF50

  • INGREDIENTS AND APPEARANCE
    NATURAL SPF 50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE780 mg  in 118 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE900 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:68062-8307-1118 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(68062-8307)
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