THEFACESHOP JELLY PACT 34200187- octinoxate, titanium oxide and zinc oxide gel gel

TheFaceShop Jelly Pact by

Drug Labeling and Warnings

TheFaceShop Jelly Pact 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 6.0 %, Titanium Dioxide 17.1, Zinc Oxide 2.9 % %,

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.

Close the cover to prevent the moisturizing ingredients from evaporating.

Directions

• Apply generously and evenly 15 minutes before sun exposure.
• Children under 6 months of age: Ask a doctor.
• Apply to all skin exposed to the sun.
• 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 an adequate amount on face in a light patting motion by using puff.

Other Information

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

May stain or damage some fabrics or surfaces

Inactive Ingredients

Mica (CI 77019), Caprylic/Capric Triglyceride, Polymethyl Methacrylate, Dimethicone, Talc, Methyl Methacrylate Crosspolymer, Diisostearyl Malate, Dimethicone/Vinyl Dimethicone Crosspolymer, Pentylene Glycol, Methicone, Lauroyl Lysine, Aluminum Hydroxide, , Silica, , Glycyrrhiza Glabra (Licorice) Root Extract, , Hydroxyapatite, Argania Spinosa Kernel Oil, Persea Gratissima (Avocado) Oil, Olea Europaea (Olive) Fruit Oil, Lilium Candidum Bulb Extract, Fragrance(Parfum), 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

JELLY PACT

SUNSCREEN GEL SPF50

01 RADIANT BEIGE

INGREDIENTS AND APPEARANCE

THEFACESHOP JELLY PACT  34200187
octinoxate, titanium oxide and zinc oxide gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-187
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	.6 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.71 g  in 10 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.29 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-187-36	1 in 1 CARTON	11/20/2014
1		10 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	11/20/2014

Labeler - THEFACESHOP CO., LTD. (688329416)

Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP Co., Ltd.		688329416	label(51523-187)