RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS- octinoxate powder

RED ORANGE SUN PACT by

Drug Labeling and Warnings

RED ORANGE SUN PACT 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%, TITANIUM DIOXIDE 3.104%, ZINC OXIDE 2.88%

INACTIVE INGREDIENT

Inactive ingredients:
Talc, Mica (CI 77019), Methyl Methacrylate Crosspolymer, Silica, Nylon-12, Ethylene/Acrylic Acid Copolymer, Methylene Bis-Benzotriazolyl Tetramethylbutylpheno, Trimethylolpropane Triethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Dimethicone, Aluminum Hydroxide, Methylparaben, MethiconeDimethicone/Methicone Copolymer, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Fragrance(Parfum), Propylparaben, Iron Oxides (CI 77499), Citrus Aurantium Dulcis (Orange) Fruit Extract, Caprylic/Capric Triglyceride, Solanum Lycopersicum (Tomato) Fruit Oil, Water

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 PACT  SPF 50 PLUS PA PLUS PLUS PLUS
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-037
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.66 g  in 9.5 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	0.29 g  in 9.5 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	0.27 g  in 9.5 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ORANGE (UNII: 5EVU04N5QU)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOMATO (UNII: Z4KHF2C175)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-037-01	9.5 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