FDA.reportPublic FDA data

Oneday Brightener Premium

Manufacturer
C'ELLA Co., Ltd.
Effective date
2019-05-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:23:09

Label at a glance#

ProductOneday Brightener Premium
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Label structure11 sections

Dosage and administration

apply liberally before sun exposure and as needed children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxycinnamate 6.0%

Octyl Salicylate 2.5%

Titanium Dioxide 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on broken or damaged skin

When using

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

INDICATIONS & USAGE SECTION

apply liberally before sun exposure and as needed

children under 6 months of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or Comments: Call Us 626-872-0164

One Day Brightener Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

One Day Brightener Label.jpg

One Day Brightener Label.jpgOne Day Brightener Label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72433-100-012021-06-23C16284748780-1ba0f9c33-2632-a910-e053-dadaa90a0b85Oneday Brightener Premium
72433-100-032021-06-23C16284748780-1ba0f9c33-2632-a910-e053-dadaa90a0b85Oneday Brightener Premium
72433-100-012021-01-29C16284748780-1ba0f9c33-2632-a910-e053-dadaa90a0b85Oneday Brightener Premium
72433-100-032021-01-29C16284748780-1ba0f9c33-2632-a910-e053-dadaa90a0b85Oneday Brightener Premium

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72433-10072433-100-01, 72433-100-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c5761e74-eae5-347b-e053-2995a90a8fcf7749bdd9-24a2-19a9-e053-2a91aa0aab802021-06-23WarningsExact identifier
spl set id: 7749bdd9-24a2-19a9-e053-2a91aa0aab80

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.