BETULA ALBA JUICE BB SPF 30 PA PLUS PLUS FOR MEN- octinoxate cream 
SKINFOOD CO., LTD.

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: OCTINOXATE 7.5%, Titanium Dioxide 4%

Inactive ingredients:
Water, Betula Platyphylla Japonica Juice, 4-Methylbenzylidene Camphor, Propylene Glycol, Butylene Glycol, Arbutin, Silica, Cetyl Alcohol, Cetyl Ethylhexanoate, Stearic Acid, Palmitic Acid, Polysorbate 60, Sorbitan Sesquioleate, Glyceryl Stearate, Tocopheryl Acetate, Dimethicone, Adenosine, Lecithin, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Stearate, Propylene Glycol Laurate, Polyacrylate-13, Polyisobutene, Sorbitan Isostearate, BHT, Triethanolamine, Propylparaben, Butylparaben, Methylparaben, Phenoxyethanol, CI 77491, CI 77492, CI 77499

Purpose: Protects skin from UV rays.

Warnings:
For external use only.
Avoid contact with eyes.
Discontinue use if signs of irritation appear.

Keep out of reach of children:
Keep out of reach of children.

Indication and usage:
After your daily skin care regimen, apply an even layer onto the face in upward and outward motions.

Dosage and administration:
Dispense an ample amount and apply a thin layer onto the skin in outward and upward motions.

Image of bottle

BETULA ALBA JUICE BB  SPF 30 PA PLUS PLUS FOR MEN
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-036
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BETULA PLATYPHYLLA VAR. JAPONICA RESIN (UNII: 1B33PG6N4K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ARBUTIN (UNII: C5INA23HXF)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PALMITIC ACID (UNII: 2V16EO95H1)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PROPYLENE GLYCOL MONOSTEARATE (UNII: F76354LMGR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-036-0150 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2011
Labeler - SKINFOOD CO., LTD. (690324173)
Registrant - SKINFOOD CO., LTD. (690324173)
Establishment
NameAddressID/FEIBusiness Operations
SKINFOOD CO., LTD.690324173manufacture

Revised: 10/2011
Document Id: 96c5bcb8-dabe-4cdd-a92c-42bee7aedf0d
Set id: 41219da4-5a95-4eaf-892d-51a1529029f7
Version: 1
Effective Time: 20111009
 
SKINFOOD CO., LTD.