b.tan Sun Safe AF SPF 50 Spray

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Sunscreen

Helps prevent sunburn
If used as directed with other sun protection measures, ( see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

For external use only

Flammable - Do not use while smoking or near heat or flame.

Do not use on damaged or broken skin.

When using this product: Keep out of eyes. Rinse with water to remove. • keep away from face to avoid breathing it • contents under pressure.
• Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face • do not apply in windy conditions • use in a well ventilated area. • Reapply: after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • children under 6 months: ask a doctor. • Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m • wear long sleeved shirts, pants, hats, and sunglasses.

Protect this product from excessive heat and direct sun.

Alcohol Denat., Acrylates/Octylacrylamide Copolymer, Stearoxytrimethylsilane, Glycerin, Fragrance (Parfum), Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Simmondsia Chinensis (Jojoba) Seed Oil, Argania Spinosa Kernel Oil, Ascorbic Acid

call 1800-914-3880

Label

B.TAN SUN SAFE AF SPF 50
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73978-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TRICAPRIN (UNII: O1PB8EU98M)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
JOJOBA OIL (UNII: 724GKU717M)
ARGAN OIL (UNII: 4V59G5UW9X)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
OCTYL ACRYLATE (UNII: EJN94319DN)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73978-007-01	170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/17/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/17/2021

Labeler - Marque of Brands Americas, LLC (081170908)

Name	Address	ID/FEI	Business Operations
Establishment
Marque of Brands Americas, LLC		081170908	manufacture(73978-007)