BO SPF15- avobenzone, octinoxate lotion 
Mana Products

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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DRUG FACTS

Active Ingredients

Avobenzone 3.00%
Octinoxate 7.50%

Use

Warnings

Directions

Inactive Ingredients

Water (Aqua), Butylene Glycol, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Hydrogenated Vegetable Oil, Glyceryl Stearate, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Oligopepetide-68, Butyrospermum Parkii (Shea) Buter, Theobroma Cacao (Cocoa) Seed Buter, Diethylhexyl Syringylidenemalonate, Ethylhexylglycerin, Coco-Glucoside, Ammonium Acryloyldimethyltaurate/VP Copolyner, Crambe Abyssinica Seed Oil, Olea Europaea (Olive) Fruit Oil, Hydrogenated Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Panthenol, Citrus Unshiu Peel Extract, Nymphaea Alba Flower Extract, Glycerin, Undecylenoyl Phenylalanine, Sodium Palmitoyl Proline, Ceteth-20, PEG-75 Stearate, Sodium Oleate, Steareth-20, Carbomer, Sodium Hydroxide, Disodium EDTA, o-Cymen-5-ol, Phenoxyethanol, Fragrance (Parfum)

Other Information

Protect this product form excessive heat and direct sun

Principal Display Panel

59735-100-01

BO SPF15 
avobenzone, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
CETETH-20 (UNII: I835H2IHHX)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
SODIUM OLEATE (UNII: 399SL044HN)  
STEARETH-20 (UNII: L0Q8IK9E08)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59735-100-0175 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/27/2013
Labeler - Mana Products (078870292)
Registrant - Mana Products (078870292)
Establishment
NameAddressID/FEIBusiness Operations
Mana Products078870292manufacture(59735-100)

Revised: 9/2013
Document Id: 74ebb324-403e-4cfe-8f15-e16e7512c936
Set id: 791a5de5-62d6-4ac6-a816-0c3b18de75f1
Version: 1
Effective Time: 20130927
 
Mana Products