Label: B.TAN BEACH PLEASE SPF 7- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 73978-009-01
- 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 March 17, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
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), Argania Spinosa (Argan) Kernel Oil, Sclerocarya Birrea (Marula) Leaf Extract, Tocopheryl Acetate, Ascorbic Acid, Panthenol
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
B.TAN BEACH PLEASE SPF 7
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73978-009 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 6 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) TRICAPRIN (UNII: O1PB8EU98M) GRAPE SEED OIL (UNII: 930MLC8XGG) PANTHENOL (UNII: WV9CM0O67Z) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) OLIVE OIL (UNII: 6UYK2W1W1E) ARGAN OIL (UNII: 4V59G5UW9X) SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C13-15 ALKANE (UNII: 114P5I43UJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73978-009-01 236 mL 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 not final part352 03/17/2021 Labeler - Marque of Brands Americas, LLC (081170908) Establishment Name Address ID/FEI Business Operations Marque of Brands Americas, LLC 081170908 manufacture(73978-009)