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 the reach of children.

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

BOOM SUN SPF 30
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68062-9910
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.75 mg in 50 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68062-9910-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/05/2022

Labeler - Spa de Soleil (874682867)