Drug Labeling and Warnings

Drug Details [pdf]

THE CURE SHEER CREAM- octinoxate, titanium dioxide cream 
Natura Bisse International

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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SPF 20
Active Ingredients
: Ethylhexyl Methoxycinnamate (Octinoxate) (4.8%), Titanium Dioxide (7.4%)

Other Ingredients: Water (Aqua), C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Polyglyceryl-4 Isostearate, Caprylic/Capric Triglyceride, Isononyl Isononanoate, Glycerin, Hydrogenated Polydecene, Beeswax, Ethylene/Acrylic Acid Copolymer, Dextrin Palmitate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Pseudoalteromonas Ferment Extract, Sodium Hyaluronate, Lepidium Sativum Sprout Extract, Tripeptide-10 Citrulline, Tripeptide-1, Urea, Lactic Acid, Sodium Lactate, Serine, Hydrolyzed Collagen, Hydrolyzed Wheat Protein, Hydrolyzed Soy Protein, Tocopheryl Acetate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Caprylate, Ethylhexylglycerin, Bisabolol, Pentylene Glycol, Sorbitol, Lecithin, Allantoin, Epsom Salt (Magnesium Sulfate), Stearic Acid, Stearalkonium Hectorite, Aluminum Stearate, Propylene Carbonate, Palmitic Acid, Silica, Butylene Glycol, Caprylyl Glycol, Xanthan Gum, Carbomer 934, Aluminum Hydroxide, Sodium Chloride, Triethanolamine, Disodium EDTA, Phenoxyethanol, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Fragrance, Alumina, Iron Oxides and Mica.

Not Tested on Animals

Uses: Helps prevent sunburn.  Higher SPF gives more sunburn protection.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.  Moderate sun protection product.  Do not use this product if the seal is broken.

Made in Spain by

Natura Bisse Int. S.A.

PQUE. Tecnol. del Valles

Cerdanyola 08290 Barcelona

image of carton label

Natura Bisse Barcelona

The Cure Sheer Cream

Color Enhanced moisturizer sunscreen

NET WT. 1.7 OZ e 50 ml.

Imported and distributed in Mexico for

Natura Bisse International S.A. de C.V.

Herschel No 50 Colonia Anzures. Delegacion Miguel Hidalgo

C.P. 11590 Mexico D.F. RFC NBI0402132PO

Expires 12 Months after opening

This Product Can Be Sold Only by Authorized Natura Bisse Retailers

THE CURE SHEER CREAM 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63730-399
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
UREA (UNII: 8W8T17847W)  
LACTIC ACID (UNII: 33X04XA5AT)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SERINE (UNII: 452VLY9402)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SORBITOL (UNII: 506T60A25R)  
ALLANTOIN (UNII: 344S277G0Z)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PALMITIC ACID (UNII: 2V16EO95H1)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER 934 (UNII: Z135WT9208)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63730-399-0150 mL in 1 CARTON; Type 0: Not a Combination Product03/08/2017
2NDC: 63730-399-022 mL in 1 CARTON; Type 0: Not a Combination Product03/08/2017
3NDC: 63730-399-037 mL in 1 CARTON; Type 0: Not a Combination Product03/08/2017
4NDC: 63730-399-0410 mL in 1 CARTON; Type 0: Not a Combination Product03/08/2017
5NDC: 63730-399-05100 mL in 1 CARTON; Type 0: Not a Combination Product03/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/08/201706/15/2019
Labeler - Natura Bisse International (464431576)
Establishment
NameAddressID/FEIBusiness Operations
Natura Bisse International464431576manufacture(63730-399)

Revised: 6/2019