Label: B.TAN SUN SAFE AF FACE SPF 70- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 73978-004-01
- Packager: Marque of Brands Americas, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 4, 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
Aluminum Starch Octenylsuccinate, Argania Spinosa Kernal Oil, Ascorbic Acid, C12-15 Alkyl Benzoate Carbomer, Dimethicone, Disodium EDTA, Ehtylhexylglycerin, Fragrance, Phenoxyethanol, Polyglyceryl-3 Distearate, Simmondsia Chinesis (Jojoba) Seed Oil, Sorbitan Isostearate, Sorbitol, Stearic Acid, Tocopherol, Triethanolamine, VP/ Eicosene Copolymer, Water.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
B.TAN SUN SAFE AF FACE SPF 70
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73978-004 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 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 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) ASCORBIC ACID (UNII: PQ6CK8PD0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) 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:73978-004-01 88 mL in 1 TUBE; 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 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(73978-004)