PHYTOGENIC INFINTE 37100457- octinoxate, titanium dioxide and zinc oxide cream cream 
THEFACESHOP CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PHYTOGENIC INFINTE 37100457

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

WATER•CYCLOPENTASILOXANE•DIPHENYLSILOXY PHENYL TRIMETHICONE•BUTYLENE GLYCOL•
GLYCERIN•NIACINAMIDE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•CETYL PEG/PPG-10/1
DIMETHICONE•PENTYLENE GLYCOL•DIMETHICONE•SODIUM CHLORIDE•TRIBEHENIN•DISTEARDIMONIUM
HECTORITE•SORBITAN ISOSTEARATE•C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER•
MICA (CI 77019)•PHENOXYETHANOL•METHYL METHACRYLATE CROSSPOLYMER•POLYESTER-1•
ALUMINUM HYDROXIDE•STEARIC ACID•SILICA DIMETHYL SILYLATE•DIMETHICONE CROSSPOLYMER•
FRAGRANCE(PARFUM)•TRIETHOXYCAPRYLYLSILANE•ETHYLHEXYLGLYCERIN•ADENOSINE•DISODIUM
EDTA•CAMELLIA SINENSIS LEAF EXTRACT•DIOSPYROS KAKI LEAF EXTRACT•HONEY EXTRACT•GINKGO
BILOBA LEAF EXTRACT•PORTULACA OLERACEA EXTRACT•BETA-GLUCAN•METHYLPARABEN•
BUTYLPARABEN•ETHYLPARABEN•ISOBUTYLPARABEN•PROPYLPARABEN•IRON OXIDES
(CI 77491, CI 77492, CI 77499)

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

Distributed by:

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

PHYTO GENIC

Infinite EX

CC cream

SPF 30 PA++

Label

PHYTOGENIC INFINTE  37100457
octinoxate, titanium dioxide and zinc oxide cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-457
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.4 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51523-457-351 in 1 CARTON11/20/2014
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/20/2014
Labeler - THEFACESHOP CO., LTD. (688329416)
Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
Establishment
NameAddressID/FEIBusiness Operations
THEFACESHOP Co., Ltd.688329416label(51523-457)

Revised: 11/2014
Document Id: 0822d47f-2987-6499-e054-00144ff88e88
Set id: 0822d47f-2986-6499-e054-00144ff88e88
Version: 1
Effective Time: 20141120
 
THEFACESHOP CO., LTD.