Label: BOOM SUN SPF 30- titanium dioxide lotion
- NDC Code(s): 68062-9910-1
- Packager: Spa de Soleil
- 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 26, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
BOOM SUN SPF 30
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-9910 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.75 mg in 50 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68062-9910-1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/05/2022 Labeler - Spa de Soleil (874682867) Establishment Name Address ID/FEI Business Operations Spa de Soleil 874682867 manufacture(68062-9910)