Label: TRU SKIN RITUALS SPF 25- titanium dioxide, zinc oxide spray

  • 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 March 18, 2023

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  • Active Ingredients

    Titanium Dioxide 4.8%

    Zinc Oxide 6.8%

  • Purpose

    Sunscreen

  • Warnings

    Warnings

    • For external use only
    • Do not use on damaged or broken skin
    • Stop use and ask a doctor if rash occurs
    • When using this product, keep out of eyes
    • Rinse with water to remove
    • Keep out of reach of children
    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    Directions

    • Apply liberally 15 minutes before sun exposure
    • Apply to all skin exposed to the sun
  • Inactive Ingredients

    Inactive Ingredients:

    Alumina, Argania Spinosa Kernel Oil, Bisabolol, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Coconut Alkanes (And) Coco-Caprylate/Caprate, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Oryza Sativa (Rice) Bran Extract, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate (Hyaluronic Acid), Stearic Acid, Tocopherol, Tocopheryl Acetate (Vitamin E)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    DIRECTIONS:

    • Apply liberally 15 minutes before sun exposure

    • Apply to all skin exposed to the sun

    Reapply:

    • after 40 minutes of swimming or sweating

    • immediately after towel drying

    • at least every 2 hours

  • PRINCIPAL DISPLAY PANEL

    Tru Skin Rituals_SPF

  • INGREDIENTS AND APPEARANCE
    TRU SKIN RITUALS SPF 25 
    titanium dioxide, zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.16 mg  in 170 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.56 mg  in 170 mL
    Inactive Ingredients
    Ingredient NameStrength
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-8801-1170 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02003/17/2023
    Labeler - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-8801)
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