PHYTOGENIC INFINTE 37100457- octinoxate, titanium dioxide and zinc oxide cream cream

PHYTOGENIC INFINTE by

Drug Labeling and Warnings

PHYTOGENIC INFINTE 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 ................5.0 %

Titanium Dioxide......6.1 %

Zinc Oxide.................5.0 %

Purpose

Sunscreen

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.
After basic skincare, apply evenly to the skin. Then pat lightly with the palms for full absorption.

Other Information

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

May stain or damage some fabrics or surfaces

Inactive Ingredients

WATERCYCLOPENTASILOXANEDIPHENYLSILOXY PHENYL TRIMETHICONEBUTYLENE GLYCOL
GLYCERINNIACINAMIDE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATECETYL PEG/PPG-10/1
DIMETHICONEPENTYLENE GLYCOLDIMETHICONESODIUM CHLORIDETRIBEHENINDISTEARDIMONIUM
HECTORITESORBITAN ISOSTEARATEC30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER
MICA (CI 77019)PHENOXYETHANOLMETHYL METHACRYLATE CROSSPOLYMERPOLYESTER-1
ALUMINUM HYDROXIDESTEARIC ACIDSILICA DIMETHYL SILYLATEDIMETHICONE CROSSPOLYMER
FRAGRANCE(PARFUM)TRIETHOXYCAPRYLYLSILANEETHYLHEXYLGLYCERINADENOSINEDISODIUM
EDTACAMELLIA SINENSIS LEAF EXTRACTDIOSPYROS KAKI LEAF EXTRACTHONEY EXTRACTGINKGO
BILOBA LEAF EXTRACTPORTULACA OLERACEA EXTRACTBETA-GLUCANMETHYLPARABEN
BUTYLPARABENETHYLPARABENISOBUTYLPARABENPROPYLPARABENIRON 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

PHYTO GENIC

Infinite EX

CC cream

SPF 30 PA++

INGREDIENTS AND APPEARANCE

PHYTOGENIC INFINTE  37100457
octinoxate, titanium dioxide and zinc oxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-457
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 g  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.4 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-457-35	1 in 1 CARTON	11/20/2014
1		40 mL in 1 TUBE; 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	11/20/2014

Labeler - THEFACESHOP CO., LTD. (688329416)

Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP Co., Ltd.		688329416	label(51523-457)