ONEDAY BRIGHTENER PREMIUM- octyl methoxycinnamate, octyl salicylate, titanium dioxide lotion

Oneday Brightener Premium by

Drug Labeling and Warnings

Oneday Brightener Premium by is a Otc medication manufactured, distributed, or labeled by C'ELLA Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octyl Methoxycinnamate 6.0%

Octyl Salicylate 2.5%

Titanium Dioxide 3.0%

Purpose

Sunscreen

Warnings

For external use only

Do not use

Do not use on broken or damaged skin

When using

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

Stop use and ask a doctor if rash or irritation occurs or lasts.

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

Directions

apply liberally before sun exposure and as needed

children under 6 months of age: ask a doctor

Inactive Ingredients

water, dipropylene glycol, glycerin, cyclopentasiloxane, niacinamide, dimethicone, c12-15 alkyl benzoate, chlorphenesin, ammonium acryloyldimethyltaurate/vp copolymer, panthenol, dimethiconol, 1,2-hexanediol, betaine, caprylyl glycol, ethylhexylglycerin, sodium polyacrylate, fragrance, cetearyl alcohol, triethoxycaprylylsilane, disodium edta, sodium hydroxide, (-)-alpha-bisabolol, cetearyl olivate, sorbitan, olivate, alcohol, malva sylvestris (mallow) extract, mentha piperita (peppermint) leaf extract, primula veris extract, cetyl peg/ppg-10/1 dimethicone, alchemilla vulgaris extract, veronica officinalis extract, melissa officinalis leaf extract, achillea millefolium extract

Questions

Questions or Comments: Call Us 626-872-0164

One Day Brightener Label

One Day Brightener Label.jpg

INGREDIENTS AND APPEARANCE

ONEDAY BRIGHTENER PREMIUM 
octyl methoxycinnamate, octyl salicylate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72433-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.2 mg  in 120 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 mg  in 120 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.6 mg  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72433-100-01	120 mL in 1 TUBE; Type 0: Not a Combination Product	10/28/2018
2	NDC: 72433-100-03	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/28/2018

Labeler - C'ELLA Co., Ltd. (692745698)

Registrant - C'ELLA Co., Ltd. (692745698)

Establishment
Name	Address	ID/FEI	Business Operations
C'ELLA Co., Ltd.		692745698	manufacture(72433-100)