FDA.reportPublic FDA data

DECORTE SHEER BRILLIANCE 40

Manufacturer
KOSE AMERICA, INC.
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:40:29

Label at a glance#

ProductDECORTE SHEER BRILLIANCE 10
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure13 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the su...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DECORTÉ Sheer Brilliance

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE

6.99%

ZINC OXIDE

6.86%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

WATER (AQUA) •CYCLOMETHICONE •ALCOHOL •LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE •ISOTRIDECYL ISONONAOATE •TRIMETHYLSILOXYSILICATE •PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE •TRIETHYLHEXANOIN •ACORUS CALAMUS ROOT EXTRACT •ALGAE OLIGOSACCHARIDES •ASTAXANTHIN •EUGENIA CARYOPHYLLUS (CLOVE) FLOWER EXTRACT •HAEMATOCOCCUS PLUVIALIS EXTRACT •PALMITOYL PENTAPEPTIDE-4 •RHODIOLA SACRA ROOT EXTRACT •SOLUBLE COLLAGEN •TOCOPHEROL •ZIZYPHUS JUJUBA FRUIT EXTRACT •ALGIN •ALUMINUM HYDROXIDE •BHT •BUTYLENE GLYCOL •CAPRYLIC/CAPRICTRIGLYCERIDE •CARBOMER •CELLULOSE •DIMETHECONE/VINYL DIMETHICONE CROSSPOLYMER •DISTEAR DIMONIUM HECTORITE •GLYCERIN •HYDROGEN DIMETHICONE •HYDROGENATED LECITHIN •ISOPROPYL TITANIUM TRIISOSTEARATE •PHYTOSTERYL OLEATE •POLYSORBATE 20 •SODIUM CHLORIDE •SODIUM LACTATE •SQUALANE •TRIETHOXYCAPRYLYLSILANE •PHENOXYETHANOL •FRAGRANCE (PARFUM) •MAY CONTAIN (+/-): IRON OXIDES (CI 77491) •IRON OXIDES (CI 77492) •IRON OXIDES (CI 77499) •MICA •TITANIUM DIOXIDE (CI 77891)

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun

Principal Display Panel - Decorte Sheet Brilliance 10 Level 50 ml Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel - Decorte Sheet Brilliance 10 Level 50 ml Carton Label
Principal Display Panel - Decorte Sheet Brilliance 10 Level 50 ml Carton Label

Principal Display Panel - Decorte Sheet Brilliance 20 Level 50 ml Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel - Decorte Sheet Brilliance 20 Level 50 ml Carton Label
Principal Display Panel - Decorte Sheet Brilliance 20 Level 50 ml Carton Label

Principal Display Panel - Decorte Sheet Brilliance 30 Level 50 ml Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel - Decorte Sheet Brilliance 30 Level 50 ml Carton Label
Principal Display Panel - Decorte Sheet Brilliance 30 Level 50 ml Carton Label

Principal Display Panel - Decorte Sheet Brilliance 40 Level 50 ml Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel - Decorte Sheet Brilliance 40 Level 50 ml Carton Label
Principal Display Panel - Decorte Sheet Brilliance 40 Level 50 ml Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66820-0110-12021-09-24C16284748780-1c7ccaba7-1cc8-fd44-e053-dadaa90aa01b745a90ef-2e00-483a-8025-6d686264278d
66820-0120-12021-09-24C16284748780-1c7ccaba7-1cc8-fd44-e053-dadaa90aa01b745a90ef-2e00-483a-8025-6d686264278d
66820-0130-12021-09-24C16284748780-1c7ccaba7-1cc8-fd44-e053-dadaa90aa01b745a90ef-2e00-483a-8025-6d686264278d
66820-0140-12021-09-24C16284748780-1c7ccaba7-1cc8-fd44-e053-dadaa90aa01b745a90ef-2e00-483a-8025-6d686264278d
66820-0110-12021-07-23C16284748780-1c7ccaba7-1cc8-fd44-e053-dadaa90aa01b745a90ef-2e00-483a-8025-6d686264278d
66820-0120-12021-07-23C16284748780-1c7ccaba7-1cc8-fd44-e053-dadaa90aa01b745a90ef-2e00-483a-8025-6d686264278d
66820-0130-12021-07-23C16284748780-1c7ccaba7-1cc8-fd44-e053-dadaa90aa01b745a90ef-2e00-483a-8025-6d686264278d
66820-0140-12021-07-23C16284748780-1c7ccaba7-1cc8-fd44-e053-dadaa90aa01b745a90ef-2e00-483a-8025-6d686264278d

Products#

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

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66820-011066820-0110-1
66820-012066820-0120-1
66820-013066820-0130-1
66820-014066820-0140-1

Ingredients#

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

DailyMed ingredient rows page 1 of 6 · 204 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
ALCOHOL3K9958V90MIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
ISOTRIDECYL ISONONANOATEWEF51750MTIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
ACORUS CALAMUS ROOTXY1K7KIQ0FIACT
HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW)M91AS4K4UKIACT
HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW)12SMS2KQK5IACT
HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW)1R4EEP8DYWIACT
HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW)UVZ8S1689CIACT
HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW)K8A98IM6B4IACT
HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW)3FDS8YD26EIACT
HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW)LK2Q17N3NIIACT
ASTAXANTHIN8XPW32PR7IIACT
CLOVEK48IKT5321IACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
PALMITOYL PENTAPEPTIDE-4KK181SM5JGIACT
RHODIOLA SACRA ROOT11R149C3CYIACT
MARINE COLLAGEN, SOLUBLE8JC99XGU4WIACT
TOCOPHEROLR0ZB2556P8IACT
JUJUBE FRUITG55HNL2C70IACT
SODIUM ALGINATEC269C4G2ZQIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POWDERED CELLULOSESMD1X3XO9MIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
HYDROLYZED ORYZANOL OLEATESCZ7DW0L6FXIACT

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
0ccc7ca0-fee0-161b-e063-6394a90a8713745a90ef-2e00-483a-8025-6d686264278d2023-12-18WarningsExact identifier
spl set id: 745a90ef-2e00-483a-8025-6d686264278d

Reported adverse events (FAERS/openFDA)#

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