B.TAN SUN SAFE AF FACE SPF 70- avobenzone, homosalate, octisalate, octocrylene lotion 
Marque of Brands Americas, LLC

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.

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b.tan Sun Safe AF

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Sunscreen

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.

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.

Directions

Protect this product from excessive heat and direct sun.

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.

call 1800-914-3880

label

B.TAN SUN SAFE AF FACE  SPF 70
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73978-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73978-004-0188 mL in 1 TUBE; Type 0: Not a Combination Product02/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/11/2021
Labeler - Marque of Brands Americas, LLC (081170908)
Establishment
NameAddressID/FEIBusiness Operations
Marque of Brands Americas, LLC081170908manufacture(73978-004)

Revised: 2/2021
Document Id: ba88a7db-90d2-168a-e053-2a95a90ae173
Set id: ba8874bf-fc0d-95e0-e053-2a95a90ae361
Version: 1
Effective Time: 20210204
 
Marque of Brands Americas, LLC