RED ORANGE SUN SPF 45 PA PLUS PLUS PLUS- titanium dioxide powder

RED ORANGE SUN by

Drug Labeling and Warnings

RED ORANGE SUN 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: TITANIUM DIOXIDE 13.937%, ZINC OXIDE 2.94%

INACTIVE INGREDIENT

Inactive ingredients:
Talc, Mica (CI 77019), Silica, Aluminum Starch Octenylsuccinate, Dimethicone, Ethylhexyl Methoxycinnamate, Methicone, Iron Oxides (CI 77492), Triethoxycaprylylsilane, Citrus Aurantium Dulcis (Orange) Peel Oil, Iron Oxides (CI 77491), Aluminum Hydroxide, Methylparaben, Iron Oxides (CI 77499), Propylparaben

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: Using the enclosed puff, apply evenly onto the entire face.

DOSAGE & ADMINISTRATION

Dosage and administration:
Give a smooth tapping massage around your skin with the enclosed puff, and reapply to areas which produce sebum secretion as often as possible to give a fresh finish.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RED ORANGE SUN  SPF 45 PA PLUS PLUS PLUS
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-038
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	2.79 g  in 20 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	0.59 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTINOXATE (UNII: 4Y5P7MUD51)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ORANGE (UNII: 5EVU04N5QU)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-038-01	20 g in 1 CARTON

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