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

b.tan Sun Safe AF by

Drug Labeling and Warnings

b.tan Sun Safe AF by is a Otc medication manufactured, distributed, or labeled by Marque of Brands Americas, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Sunscreen

INDICATIONS & USAGE

• 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.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

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

QUESTIONS

call 1800-914-3880

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/17/2021

Labeler - Marque of Brands Americas, LLC (081170908)

Establishment
Name	Address	ID/FEI	Business Operations
Marque of Brands Americas, LLC		118733944	manufacture(73978-007)