HUXLEY MOIST CUSHION OWN ATTITUDE 3 SAND DUNE- titanium dioxide, octinoxate, octisalate cream 
Nord Mason Co., Ltd.

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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72480-003_HUXLEY MOIST CUSHION OWN ATTITUDE 3 SAND DUNE

Titanium Dioxide 11.264%

Octinoxate 6.700%

Octisalate 4.000%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure.

Reapply at least every two hours

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 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

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 using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Opuntia Ficus-Indica Stem Extract, Water, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Dipropylene Glycol, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Methyl Trimethicone, Dimethicone, 1,2-Hexanediol, Mica (CI 77019), Iron Oxides (CI 77492), PEG-10 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Isododecane, Methyl Methacrylate Crosspolymer, Stearic Acid, Alumina, Acrylates/ Polytrimethylsiloxymethacrylate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxycaprylylsilane, Fragrance(Parfum), Aluminum Hydroxide, Iron Oxides (CI 77491), Butylene Glycol, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Glyceryl Caprylate, Iron Oxides (CI 77499), Disodium EDTA, Opuntia Ficus-Indica Seed Oil, Balanites Roxburghii Seed Oil, Cassia Angustifolia Seed Polysaccharide, Phenoxyethanol, Tocopherol

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HUXLEY MOIST CUSHION OWN ATTITUDE 3 SAND DUNE 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72480-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.3516 g  in 12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.804 g  in 12 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.48 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
ISODODECANE (UNII: A8289P68Y2)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J)  
BALANITES ROXBURGHII SEED OIL (UNII: CZ67V4ZW0I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72480-003-021 in 1 CARTON08/29/201811/02/2020
1NDC:72480-003-0112 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:72480-003-041 in 1 CARTON08/29/201811/02/2020
2NDC:72480-003-0312 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/29/201811/02/2020
Labeler - Nord Mason Co., Ltd. (690491447)
Registrant - Nord Mason Co., Ltd. (690491447)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(72480-003)

Revised: 11/2020
 
Nord Mason Co., Ltd.