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

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

Do not use on damaged or broken skin.

When using this product: Keep out of eyes. Rinse with water to remove.

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

• Apple liberally 15 minutes before sun exposure.
• Reapply: after 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• Children under 6 months of age: ask a doctor.
• Sun Protection Measures.
• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10am-2pm
• Wear long-sleeved shirts, pants, hats and sunglasses.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

Water (Aqua), Sorbitol, Aluminum Starch Octenylsuccinate, VP/ Eicosene Copolymer, Stearic Acid, Phenoxyethanol, Polyglyceryl-3 Distearate, Sorbitan Isostearate, Triethanolamine, Dimethicone, Fragrance (Parfum), Benzyl Alcohol, Carbomer, Disodium EDTA, Ehtylhexylglycerin, Tocopherol, Simmondsia Chinesis (Jojoba) Seed Oil, Argania Spinosa (Argan) Kernal Oil, Ascorbic Acid (Vitamin C)

QUESTIONS

call 1800-914-3880

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73978-006
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
TROLAMINE (UNII: 9O3K93S3TK)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITOL (UNII: 506T60A25R)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARIC ACID (UNII: 4ELV7Z65AP)
JOJOBA OIL (UNII: 724GKU717M)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARGAN OIL (UNII: 4V59G5UW9X)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73978-006-01	207 mL in 1 TUBE; Type 0: Not a Combination Product	03/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/16/2021

Labeler - Marque of Brands Americas, LLC (081170908)

Establishment
Name	Address	ID/FEI	Business Operations
Marque of Brands Americas, LLC		118733944	manufacture(73978-006)