THE CELLIN SUN SCREEN SPF35 PA PLUS PLUS- octinoxate, titanium dioxide, octisalate cream

THE CELLIN SUN SCREEN by

Drug Labeling and Warnings

THE CELLIN SUN SCREEN by is a Otc medication manufactured, distributed, or labeled by Cellinbio Co Ltd, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: Octinoxate 7.50%, Titanium Dioxide 5.19%, Octisalate 3.00%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Cyclopentasiloxane, Glycerin, Dipropylene Glycol, Peg-10 Dimethicone, Hexyl Laurate, Talc, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Diste-ardimonium Hectorite, Magnesium Sulfate, Aluminum Hydroxide, Aluminum Stearate, Fragrance, lmidazolidinyl Urea, Methylparaben, Propylparaben, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lavandula Angustifolia(Lavender) Extract, Panax Ginseng Root Extract, Squalane, Iron Oxides(CI77492, CI77491, CI77499), Butylparaben, Methicone

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
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 prevent sunburn, not skin cancer or early skin aging.
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

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

DESCRIPTION

Uses: Helps prevent sunburn

Directions:
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months : Ask a doctor

Other information:
Protect this product from excessive heat and direct sun

Questions or comments: 213-325-2780

Shelf Life 3years

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE CELLIN SUN SCREEN  SPF35 PA PLUS PLUS
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76173-1101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	5.62 mg  in 75 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.89 mg  in 75 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.25 mg  in 75 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76173-1101-1	75 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2014

Labeler - Cellinbio Co Ltd (557803737)

Registrant - Cellinbio Co Ltd (557803737)

Establishment
Name	Address	ID/FEI	Business Operations
Cellinbio Co Ltd		557803737	relabel(76173-1101)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		688732723	manufacture(76173-1101)