Drug Labeling and Warnings

Drug Details [pdf]

THE CURE OIL-FREE- octinoxate, titanium dioxide cream 
Natura Bisse International SA

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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Active Ingredients                                      Purpose

Octinoxate 4.8%               

Titanium Dioxide 6.3%  }                           Sunscreen

Uses

Helps prevent sunburn

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Natura Bisse

Barcelona

THE CURE

SHEER 

OIL-FREE FLUID

Hidratante detox con color

Color enhanced moisturizer

Emulsion Hydratante Teintee

Mit Farbpitmenten angereicherte

Feuchtigkeitscreme

Hidratante detox com cor

Idratante intenso colorato

SUNSCREEN

Broad spectrum SPF 20

Net Wt. 1.7 oz. e 50 ml

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

Directions

  • apply liberally 15 minutes before skin exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
  • 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 sun-glasses

Water, Cyclopentasiloxane, Glycerin, Diisopropyl Sebacate, Ethylene/Acrylic Acid Copolymer, Caprylic/Capric Triglyceride, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Glyceryl Linoleate, Arginine, Hydrolyzed Collagen, Bisabolol, Lactic Acid, Sodium Lactate, Serine, Sorbitol, Urea, Glyceryl Linolenate, Niacinamide, Yeast Extract, Aesculus
Hippocastanum (Horse Chestnut) Seed Extract, Sodium Hyaluronate, Ammonium Glycyrrhizate, Zinc Gluconate, Panthenol, Allantoin, Caffeine, Biotin, Palmitoyl Tripeptide-38, Lepidium Sativum Sprout Extract, Aluminum Hydroxide, Sodium Chloride, Stearic Acid, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Triethoxycaprylylsilane, Silica Silylate, Stearalkonium Hectorite, Dimethiconol, Disodium EDTA, Palmitamidopropyltrimonium Chloride, Dimethicone Crosspolymer, Propylene Carbonate, Ethylhexylglycerin,
Pentylene Glycol, Hydroxypropyl Cyclodextrin, Sodium Citrate, Citric Acid, Lecithin, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Fragrance (Parfum), Iron Oxides (CI 77492, CI 77491, CI 77499).

Other information protect this product from excessive heat and direct sun.

Questions? 1-800-762-8872

ESTE PROUCTO SOLO PUEDE VENDERSE EN ESTABLECIMIENTOS AUTORIZADOS POR NATURA BISSE

THIS PRODUCT CAN BE SOLD ONLY BY AUTHORIZED NATURA BISSE RETAILERS

image description

THE CURE OIL-FREE 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63730-392
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ARGININE (UNII: 94ZLA3W45F)  
GELATIN (UNII: 2G86QN327L)  
LEVOMENOL (UNII: 24WE03BX2T)  
LACTIC ACID (UNII: 33X04XA5AT)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SERINE (UNII: 452VLY9402)  
SORBITOL (UNII: 506T60A25R)  
UREA (UNII: 8W8T17847W)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
NIACINAMIDE (UNII: 25X51I8RD4)  
YEAST (UNII: 3NY3SM6B8U)  
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
CAFFEINE (UNII: 3G6A5W338E)  
BIOTIN (UNII: 6SO6U10H04)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
LEPIDIUM SATIVUM SEED (UNII: WZM06UL78H)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIPHENYL DIMETHICONE (100 CST) (UNII: AG1ANB6B8O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63730-392-0150 g in 1 BOTTLE; Type 0: Not a Combination Product03/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/08/201706/15/2019
Labeler - Natura Bisse International SA (464431576)
Establishment
NameAddressID/FEIBusiness Operations
Natura Bisse International SA464431576manufacture(63730-392)

Revised: 6/2019