BETULA ALBA JUICE BB SPF 30 PA PLUS PLUS FOR MEN- octinoxate cream

BETULA ALBA JUICE BB by

Drug Labeling and Warnings

BETULA ALBA JUICE BB by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: OCTINOXATE 7.5%, Titanium Dioxide 4%

INACTIVE INGREDIENT

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

Purpose: Protects skin from UV rays.

WARNINGS

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:
Keep out of reach of children.

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BETULA ALBA JUICE BB  SPF 30 PA PLUS PLUS FOR MEN
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-036
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	2 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-036-01	50 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2011

Labeler - SKINFOOD CO., LTD. (690324173)

Registrant - SKINFOOD CO., LTD. (690324173)

Establishment
Name	Address	ID/FEI	Business Operations
SKINFOOD CO., LTD.		690324173	manufacture