PHYTOGENIC INFINTE EX 37100453- octinoxate and titanium dioxide powder powder

PHYTOGENIC INFINTE EX by

Drug Labeling and Warnings

PHYTOGENIC INFINTE EX by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD., THEFACESHOP NORTH AMERICA, INC., THEFACESHOP Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 2.0 %

Titanium Dioxide 14.0 %,

Purpose

Sunscreen

Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and
evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor
Skin Cancer/Skin Aging Alert: Spending time in the sun increases
your risk of skin cancer and early skin aging. This product has been
shown only to help prevent sunburn, not skin cancer or early skin aging.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
Apply onto face in a light patting motion with enclosed puff. For contours
around the eyes and nose, apply with extra care.

Other Information

Protect the product in this container from excessive heat and direct sun

May stain or damage some fabrics or surfaces

Inactive Ingredients

TALCSILICANYLON-12DIISOSTEARYL MALATEPENTAERYTHRITYL
TETRAISOSTEARATEHYDROGENATED POLY(C6-14 OLEFINMETHICONE
CAPRYLIC/CAPRIC TRIGLYCERIDEDIMETHICONEDEA-C8-18
PERFLUOROALKYLETHYL PHOSPHATEHYDROGENATED LECITHIN
METHYLPARABENFRAGRANCE(PARFUM)PROPYLPARABENMONTMORILLONITE
ALUMINUM STARCH OCTENYLSUCCINATEHDI/TRIMETHYLOL HEXYLLACTONE
CROSSPOLYMERWATERBUTYLENE GLYCOLASPALATHUS LINEARIS EXTRACT
LILIUM CANDIDUM FLOWER EXTRACTBORAGO OFFICINALIS EXTRACTSALVIA
OFFICINALIS (SAGE) LEAF EXTRACTCENTAUREA CYANUS FLOWER EXTRACT
ANTHEMIS NOBILIS FLOWER EXTRACTMICA (CI 77019)
IRON OXIDES (CI 77491, CI 77492, CI 77499)

QUESTIONS

Questions or comments? Call 1 (866) 638-8417

Distributed by:

THEFACESHOP NORTH AMERICA, INC.
Santa Fe Springs, CA 90670

PRINCIPAL DISPLAY PANEL

PHYTOGENIC

Infinite EX

NB25

sunscreen powder foundation

SPF20

INGREDIENTS AND APPEARANCE

PHYTOGENIC INFINTE EX  37100453
octinoxate and titanium dioxide powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-453
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	.24 g  in 12 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	1.68 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-453-32	1 in 1 CARTON	11/20/2014
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/19/2014

Labeler - THEFACESHOP CO., LTD. (688329416)

Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP Co., Ltd.		688329416	label(51523-453)