DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY- avobenzone, octinoxate, octisalate cream

DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY by

Drug Labeling and Warnings

DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY by is a Otc medication manufactured, distributed, or labeled by KOSE AMERICA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Avobenzone 3.00%

Octinoxate 7.49%

Octisalate 1.00%

PURPOSE

Sunscreen

USES

• Helps Prevent Sunburn

DIRECTIONS FOR USE:

• Use in the morning after cleansing skin, or as the final step of your skincare routine. Take an appropriate amount and apply.
• When using foundation, use after applying this product.
• Use a facial cleanser for easy removal.
• lf product enters eyes, rinse with water.
• Close cap after each use.
• Store away from high temperatures.

WARNINGS

For external use only.

DO NOT USE

Do not useon damaged or broken skin.

WHEN USING

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

STOP USE

Stop use and ask a doctorif rash occurs.

KEEP OUT OF REACH OF CHILDREN

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 value 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 INGREDIENT

Water/AQUA/EAU, Butylene Glycol, Hydrogenated Polydecene, Behenyl Alcohol, Squalane, Polyglyceryl-6 Stearate, Phytosteryl Macadamiate, Glycerin, Caprylic/Capric Triglyceride, Pentylene Glycol, Sorbitol, Glyceryl Stearate SE, Betula Platyphylla Japonica Bark Extract, Betula Platyphylla Japonika Juice, Camellia Sinensis Leaf Extract, Crataegus Cuneata Fruit Extract, Glycine, Glycine Soja (Soybean) Seed Extract, Hydrolyzed Collagen, Hydroxyproline, Michelia Champaca Flower Extract, Mucuna Birdwoodiana Stem Extract, Palmitoyl Pentapeptide-4, Pyrus Cydonia Seed Extract, Santalum Album (Sandalwood) Wood Extract, Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Tocopherol, Alcohol, Algin, BHT, Carbomer, Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Disodium Succinate, Hydrogenated Lecithin, Phytosteryloleate, Polysorbate 20, Sodium Lactate, Sodium Stearoyl Glutamate, Succinic Acid, Xanthan Gum, Phenoxyethanol, Fragrance (Parfum)

Other information

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 45 mL CYLINDER

DECORTÉ AQ

ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY CREAM BROAD SPECTRUM SPF 16 SUNSCREEN

e 45 mL NET WT. 1.5 OZ.

INGREDIENTS AND APPEARANCE

DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY 
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66820-0500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.945 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
ALCOHOL (UNII: 3K9958V90M)
SQUALANE (UNII: GW89575KF9)
DOCOSANOL (UNII: 9G1OE216XY)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SORBITOL (UNII: 506T60A25R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BETULA PLATYPHYLLA RESIN (UNII: 1B33PG6N4K)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCINE (UNII: TE7660XO1C)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
HYDROLYZED ORYZANOL OLEATES (UNII: CZ7DW0L6FX)
HYDROXYPROLINE (UNII: RMB44WO89X)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
MUCUNA BIRDWOODIANA STEM (UNII: 6W7VXE8RS6)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
CRATAEGUS CUNEATA FRUIT (UNII: 98TEA9T639)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MARINE NON-GELLING GELATIN (UNII: JSM64OJO9B)
SODIUM LACTATE (UNII: TU7HW0W0QT)
MICHELIA CHAMPACA FLOWER (UNII: VOT99IIA37)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SUCCINIC ACID (UNII: AB6MNQ6J6L)
SOYBEAN (UNII: L7HT8F1ZOD)
BETULA PLATYPHYLLA BARK (UNII: ZF70YKN0YO)
SANDALWOOD (UNII: 3641YW25N2)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66820-0500-1	1 in 1 CARTON	05/16/2024
1		45 mL in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/16/2024

Labeler - KOSE AMERICA, INC. (080407621)