THE CURE OIL-FREE- octinoxate, titanium dioxide cream

The Cure Oil-Free by

Drug Labeling and Warnings

The Cure Oil-Free by is a Otc medication manufactured, distributed, or labeled by Natura Bisse International SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                      Purpose

Octinoxate 4.8%               

Titanium Dioxide 6.3%  }                           Sunscreen

PURPOSE

Uses

Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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 SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE CURE OIL-FREE 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63730-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
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)
GLYCERYL LINOLEATE (UNII: 4763AXI84L)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63730-222-01	50 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/21/2014

Labeler - Natura Bisse International SA (464431576)

Establishment
Name	Address	ID/FEI	Business Operations
Natura Bisse International SA		464431576	manufacture(63730-222)