OTHREE 50 WHITENING- titanium dioxide, zinc oxide, octinoxate, octocrylene cream

Othree 50 Whitening by

Drug Labeling and Warnings

Othree 50 Whitening by is a Otc medication manufactured, distributed, or labeled by CELLAB CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 7.5%

Octocrylene 6%

Zinc Oxide 5%

Titanium Dioxide 4.92%

INACTIVE INGREDIENT

Water

Cyclomethicone 5

Cetyl Peg/ppg-10/1 dimethicone (hlb2)

sodium chroride

Niacinamide

Disteardimonium hectorite

Polyglyceryl-4 isostearate

sorbitan dioleate

phenyl trimethicone

acai

chamomile

rosemary

lavandula angustifolia flower

stearic acid

aluminum hydroxide

silicon dioxide

magnesium aluminum silicate

dimethicone/vinyl dimethicone crosspolymer

dimethicone

microcrystalline wax

yellow wax

sorbitan isostearate

hexyl laurate

allantoin

dipropylene glycol

ferric oxide yellow

ferric oxide red

.alpha.-tocopherol acetate

propylparaben

methylparaben

methylparaben

edetate disodium

ASK DOCTOR

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Use

As the final step in skin care, apply a proper amount evenly over the entire face and neck to protect against harmful UV rays. Apply 30 minutes before sun exposure for more effective result.

WARNINGS

For external use only. Avoid eyes: if contact or adverse reaction occurs, rinse well and consult physician immediately. Do not use on infants.

PURPOSE

Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OTHREE 50 WHITENING  
titanium dioxide, zinc oxide, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57557-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.936 g  in 80 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4 g  in 80 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 80 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.8 g  in 80 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57557-100-02	1 in 1 CARTON	04/03/2013
1	NDC: 57557-100-01	80 g 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	04/03/2013

Labeler - CELLAB CO., LTD. (688195494)

Registrant - CELLAB CO., LTD. (688195494)

Establishment
Name	Address	ID/FEI	Business Operations
CELLAB CO., LTD.		688195494	manufacture(57557-100)