Label: BOOM SUN SPF 30- titanium dioxide 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 26, 2022

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  • Active Ingredients

    Titanium Dioxide 7.5%

  • 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 the reach of children.

  • Directions

    Directions

    Shake well before use

    Using the bulb pipette, dispense 4-6 drops in the palm of the hand.
    Rub hands together, then apply liberally and evenly to the face using a circular motion.
    Allow 15 minutes after application before sun exposure.
    Reapply every 2 hours and after swimming or sweating.
    Children under 6 months of age: Ask a doctor.
    Protect the product in this container from excessive heat.

  • Inactive Ingredients

    Inactive Ingredients:

    Isopropyl Palmitate, Coconut Alkanes (and) Coco Caprylate/Caprate, Caprylic/Capric Triglyceride, Heptyl Undecylenate, Argania Spinosa Kernel Oil, Stearic Acid, *Squalane, Alumina, Oryza Sativa (Rice) Bran Extract, Polyhydroxystearic Acid, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Extract, Tocopherol, Tocopheryl Acetate (Vitamin E)
    * From Sugarcane

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    BOOM SUN SPF 30 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9910
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.75 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    SQUALANE (UNII: GW89575KF9)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-9910-150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/05/2022
    Labeler - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-9910)
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