Label: B.TAN SUN SAFE AF SPF 50- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 73978-007-01
- 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 March 17, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face • do not apply in windy conditions • use in a well ventilated area. • Reapply: after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • children under 6 months: ask a doctor. • Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m • wear long sleeved shirts, pants, hats, and sunglasses.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
B.TAN SUN SAFE AF SPF 50
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73978-007 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ASCORBIC ACID (UNII: PQ6CK8PD0R) TRICAPRIN (UNII: O1PB8EU98M) GLYCERIN (UNII: PDC6A3C0OX) TOCOPHEROL (UNII: R0ZB2556P8) STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2) JOJOBA OIL (UNII: 724GKU717M) ARGAN OIL (UNII: 4V59G5UW9X) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) OCTYL ACRYLATE (UNII: EJN94319DN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73978-007-01 170 g 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 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(73978-007)
