B.TAN TROPIC LIKE ITS HOT SPF 15- avobenzone, homosalate, octisalate, octocrylene spray

b.tan Tropic Like Its Hot by

Drug Labeling and Warnings

b.tan Tropic Like Its Hot 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 6%, Octisalate 5%, Octocrylene 8%

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. Keep away from face to avoid breathing it.

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

Caprylic/ Capric Triglyceride, VP/Hexadecene Copolymer, Silica, C13-14 Alkane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Vitis Vinifera (Grape) Seed Oil, Fragrance (Parfum), Tocopheryl Acetate, Ascorbic Acid, Panthenol, Citrus Paradisi (Grapefruit) Oil, Citrus Reticulata (Tangerine) Peel Oil, Niacinamide (Vitamin B3)

QUESTIONS

call 1800-914-3880

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

B.TAN TROPIC LIKE ITS HOT  SPF 15
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73978-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 mg  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PANTHENOL (UNII: WV9CM0O67Z)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
OLIVE OIL (UNII: 6UYK2W1W1E)
GRAPEFRUIT OIL (UNII: YR377U58W9)
MANDARIN OIL (UNII: NJO720F72R)
NIACINAMIDE (UNII: 25X51I8RD4)
C13-15 ALKANE (UNII: 114P5I43UJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73978-005-01	236 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/11/2021

Labeler - Marque of Brands Americas, LLC (081170908)

Establishment
Name	Address	ID/FEI	Business Operations
Marque of Brands Americas, LLC		081170908	manufacture(73978-005)