DECORTE AQ UV PROTECTION- titanium dioxide, zinc oxide cream

DECORTE AQ UV PROTECTION by

Drug Labeling and Warnings

DECORTE AQ UV PROTECTION by is a Otc medication manufactured, distributed, or labeled by KOSE AMERICA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

TITANIUM DIOXIDE 10.79%
ZINC OXIDE 6.51%

Purpose

Sunscreen

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 a 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 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 ingredients

WATER/AQUA/EAU · DIPHENYLSILOXY PHENYL TRIMETHICONE · CYCLOPENTASILOXANE · DIMETHICONE · NEOPENTYL GLYCOL DIETHYLHEXANOATE · PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE · VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER · GLYCERIN · TALC · BUTYLENE GLYCOL · PENTYLENE GLYCOL · POLYMETHYLSILSESQUIOXANE · ALUMINUM HYDROXIDE · STEARIC ACID · MAGNESIUM SULFATE · SORBITAN SESQUIISOSTEARATE · DISODIUM ADENOSINE TRIPHOSPHATE · HYDROLYZED COLLAGEN · IMPATIENS BALSAMINA FLOWER/LEAF/STEM EXTRACT · LONICERA CAERULEA FRUIT JUICE · MALVA SYLVESTRIS (MALLOW) EXTRACT · MUCUNA BIRDWOODIANA STEM EXTRACT · OLEA EUROPAEA (OLIVE) LEAF EXTRACT · PALMITOYL PENTAPEPTIDE-4 · SANTALUM ALBUM (SANDALWOOD) WOOD EXTRACT · TILIA EUROPAEA FLOWER EXTRACT · TOCOPHEROL · URTICA DIOICA (NETTLE) LEAF EXTRACT · ACRYLATES/DIMETHICONE COPOLYMER · ALCOHOL · ALGIN · CARBOMER · DIMETHICONE/PEG-10/15 CROSSPOLYMER · DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER · DIPROPYLENE GLYCOL · ECTOIN · HYDROGEN DIMETHICONE · POLYSORBATE 20 · SODIUM CITRATE · SODIUM LACTATE · XANTHAN GUM · PHENOXYETHANOL · FRAGRANCE (PARFUM) · IRON OXIDES (Cl 77491) · IRON OXIDES (Cl 77492) · IRON OXIDES (Cl 77499)

Other information

Protect this product from excessive heat and direct sun

Principal Display Panel

0.5 mL Packet

DECORTE AQ

UV PROTECTION

Chemical UV Absorber Free

Broad Spectrum SPF 40

Sunscreen

0.5 mL NET WT. .02 OZ.

5 mL Tube

DECORTE AQ

UV PROTECTION

Chemical UV Absorber Free

Broad Spectrum SPF 40

Sunscreen

e 5 mL NET WT. .21 OZ.

50 mL Carton

DECORTE AQ

UV PROTECTION

Chemical UV Absorber Free

Broad Spectrum SPF 40

Sunscreen

e 50 mL NET WT. 2.1 OZ.

INGREDIENTS AND APPEARANCE

DECORTE AQ UV PROTECTION 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66820-0300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	128.452381 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	77.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
WATER (UNII: 059QF0KO0R)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)
MARINE NON-GELLING GELATIN (UNII: JSM64OJO9B)
IMPATIENS BALSAMINA FLOWERING TOP (UNII: 7S287B0Z5V)
LONICERA CAERULEA FRUIT JUICE (UNII: NZG59YZW09)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
MUCUNA BIRDWOODIANA STEM (UNII: 6W7VXE8RS6)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
SANDALWOOD (UNII: 3641YW25N2)
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
TOCOPHEROL (UNII: R0ZB2556P8)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
ALCOHOL (UNII: 3K9958V90M)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ECTOINE (UNII: 7GXZ3858RY)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM LACTATE (UNII: TU7HW0W0QT)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66820-0300-1	1 in 1 CARTON	03/01/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 66820-0300-2	5 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2022
3	NDC: 66820-0300-3	0.5 mL in 1 PACKET; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2022

Labeler - KOSE AMERICA, INC. (080407621)