Label: B.TAN TROPIC LIKE ITS HOT SPF 15- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 73978-005-01
- Packager: Marque of Brands Americas, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 11, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
B.TAN TROPIC LIKE ITS HOT SPF 15
avobenzone, homosalate, octisalate, octocrylene sprayProduct 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)