Label: DECORTE AQ UV PROTECTION- titanium dioxide, zinc oxide cream
- NDC Code(s): 66820-0300-1, 66820-0300-2, 66820-0300-3
- Packager: KOSE AMERICA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 24, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
-
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
-
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 creamProduct 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 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 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 final part352 03/01/2022 Labeler - KOSE AMERICA, INC. (080407621)