BOOM SUN SPF 30- titanium dioxide lotion

Boom Sun SPF 30 by

Drug Labeling and Warnings

Boom Sun SPF 30 by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BOOM SUN SPF 30 
titanium dioxide lotion

Product 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)