DECORTE SHEER BRILLIANCE 10- octinoxate, zinc oxide lotion
DECORTE SHEER BRILLIANCE 20- octinoxate, zinc oxide lotion
DECORTE SHEER BRILLIANCE 30- octinoxate, zinc oxide lotion
DECORTE SHEER BRILLIANCE 40- octinoxate, zinc oxide lotion
KOSÉ CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DECORTÉ Sheer Brilliance

Drug Facts

Active ingredients

OCTINOXATE

6.99%

ZINC OXIDE

6.86%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

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 doctor if rash occurs.

Keep out of reach of children.

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

Directions

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:

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

Protect this product from excessive heat and direct sun

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

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

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

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

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 20 Level 50 ml Bottle Label

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

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

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

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 30 Level 50 ml Bottle Label

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

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

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

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 40 Level 50 ml Bottle Label

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

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

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

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

DECORTE SHEER BRILLIANCE 10
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63903-0110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.9 g in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.8 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALCOHOL (UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
ASTAXANTHIN (UNII: 8XPW32PR7I)
CLOVE (UNII: K48IKT5321)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
RHODIOLA SACRA ROOT (UNII: 11R149C3CY)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
TOCOPHEROL (UNII: R0ZB2556P8)
JUJUBE FRUIT (UNII: G55HNL2C70)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SQUALANE (UNII: GW89575KF9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63903-0110-1	1 in 1 CARTON	09/01/2017	05/01/2018
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/01/2017	05/01/2018

DECORTE SHEER BRILLIANCE 20
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63903-0120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.9 g in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.8 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALCOHOL (UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
ASTAXANTHIN (UNII: 8XPW32PR7I)
CLOVE (UNII: K48IKT5321)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
RHODIOLA SACRA ROOT (UNII: 11R149C3CY)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
TOCOPHEROL (UNII: R0ZB2556P8)
JUJUBE FRUIT (UNII: G55HNL2C70)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SQUALANE (UNII: GW89575KF9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63903-0120-1	1 in 1 CARTON	09/01/2017	05/01/2018
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/01/2017	05/01/2018

DECORTE SHEER BRILLIANCE 30
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63903-0130
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.9 g in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.8 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALCOHOL (UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
ASTAXANTHIN (UNII: 8XPW32PR7I)
CLOVE (UNII: K48IKT5321)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
RHODIOLA SACRA ROOT (UNII: 11R149C3CY)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
TOCOPHEROL (UNII: R0ZB2556P8)
JUJUBE FRUIT (UNII: G55HNL2C70)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SQUALANE (UNII: GW89575KF9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63903-0130-1	1 in 1 CARTON	09/01/2017	05/01/2018
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/01/2017	05/01/2018

DECORTE SHEER BRILLIANCE 40
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63903-0140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.0 g in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.9 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALCOHOL (UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
ASTAXANTHIN (UNII: 8XPW32PR7I)
CLOVE (UNII: K48IKT5321)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
RHODIOLA SACRA ROOT (UNII: 11R149C3CY)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
TOCOPHEROL (UNII: R0ZB2556P8)
JUJUBE FRUIT (UNII: G55HNL2C70)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SQUALANE (UNII: GW89575KF9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63903-0140-1	1 in 1 CARTON	09/01/2017	05/01/2018
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/01/2017	05/01/2018

Labeler - KOSÉ CORPORATION (690543525)

Revised: 5/2018

Document Id: 20184827-0a96-4d1b-8735-f66a9238c440

Set id: 01ad9614-cf05-4b4d-9289-4c0c188cb7ca

Version: 2

Effective Time: 20180501

KOSÉ CORPORATION