RED ORANGE JELLY BB SPF20 PA PLUS PLUS NO.1- titanium dioxide cream

RED ORANGE JELLY BB by

Drug Labeling and Warnings

RED ORANGE JELLY 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 ingredient: TITANIUM DIOXIDE 9.29%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Hydrogenated Polyisobutene, Dipropylene Glycol, Butylene Glycol, Dimethicone, Sorbitan Isostearate, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Stearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Chlorphenesin, Aluminum Hydroxide, Triethoxycaprylylsilane, Isohexadecane, Iron Oxides (CI 77491), Propylparaben, Iron Oxides (CI 77499), Polysorbate 80, Disodium EDTA, Fragrance(Parfum), Citrus Aurantium Dulcis (Orange) Fruit Extract, Caprylic/Capric Triglyceride, Solanum Lycopersicum (Tomato) Fruit Oil

PURPOSE

Purpose: UVA/UVB protection

WARNINGS

Warnings:
For external use only.
Avoid contact with eyes.
Do not swallow.
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.
For maximum coverage, reapply the BB cream on hyper pigmentation areas.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RED ORANGE JELLY BB  SPF20 PA PLUS PLUS NO.1
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-042
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	2.32 g  in 25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOHEXADECANE (UNII: 918X1OUF1E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ORANGE (UNII: 5EVU04N5QU)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOMATO (UNII: Z4KHF2C175)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-042-01	25 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