DECORTE AQ UV PROTECTION- titanium dioxide, zinc oxide cream 
KOSE AMERICA, INC.

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.

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DECORTE AQ UV PROTECTION-titanium dioxide, zinc oxide cream

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:

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.

50 mL-Carton

DECORTE AQ UV PROTECTION 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66820-0300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE128.452381 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE77.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66820-0300-11 in 1 CARTON03/01/2022
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:66820-0300-25 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2022
3NDC:66820-0300-30.5 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2022
Labeler - KOSE AMERICA, INC. (080407621)

Revised: 11/2022
Document Id: ee3c4a33-e994-da48-e053-2995a90a09cb
Set id: c6bddc60-2a00-4405-9c4a-48626ee55eb4
Version: 2
Effective Time: 20221124
 
KOSE AMERICA, INC.