DAILY MOISTURIZER BROAD-SPECTRUM SPF 30- avobenzone, octinoxate, octisalate 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%

Octisalate 5.0%

Use

Helps prevent sunburn. If used as directed with other sun protection measures, helps decrease the risk of skin cancer and early signs of aging caused by the sun.

Warnings

Directions

Inactive Ingredients

Water (Aqua, Eau), Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Butylene Glycol, Mica, Titanium Dioxide (CI 77891), Glycerin, Simmondsia Chinensis Seed Oil, Butyrospermum Parkii (Shea) Butter, Hexapeptide-33, Stearic Acid, Behenyl Alcohol, Glyceryl Stearate, Lecithin,Myristyl Alcohol, Lauryl Alcohol, Cetyl Alcohol, Palmitic Acid, Cetearyl Alcohol, Coco-Glucoside, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Prunus Armeniaca Kernel Oil, Carica Papaya Fruit Extract, Cymbopogon Schoenanthus Extract, Aesculus Hippocastanum Seed Extract, Aloe Barbadensis Leaf Extract, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide, Propylene Glycol Laurate, Ethylhexylglycerin, Disodium Edta, Phenoxyethanol, o-Cymen-5-Ol, Fragrance (Parfum), Benzyl Alcohol, Benzyl Salicylate, Butylphenyl Methylpropional, d-Limonene

Other Information

Protect this product form excessive heat and direct sun

Principal Display Panel

59735-130-01

DAILY MOISTURIZER BROAD-SPECTRUM SPF 30 
avobenzone, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-130
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BEHENYL BENZOATE (UNII: DQG8119XKJ)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
LAURYL ALCOHOL (UNII: 178A96NLP2)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PALMITIC ACID (UNII: 2V16EO95H1)  
COCO GLUCOSIDE (UNII: ICS790225B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
PRUNUS ARMENIACA LEAF (UNII: 0X5YG5R83N)  
CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
AESCULUS HIPPOCASTANUM LEAF (UNII: Z49U891FNQ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
SODIUM HYDRIDE (UNII: 23J3BHR95O)  
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
LIMONENE, DL- (UNII: 9MC3I34447)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59735-130-0150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/27/2014
Labeler - Mana Products (078870292)

Revised: 1/2014
Document Id: 63b32367-3208-4427-bad3-c9c17fe4f1ec
Set id: fe229de2-6385-43a2-9439-e93ec4fd3d6a
Version: 1
Effective Time: 20140127
 
Mana Products