MARCELLE CC CREAM COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate and oxybenzone cream 
Groupe Marcelle Inc.

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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Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35

Drug Facts

Active Ingredients    Purpose

Octinoxate 7.5%         Sunscreen

Oxybenzone 3.0%       Sunscreen

Uses

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.

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

Directions

    - after 40 minutes of swimming or sweating

    - immediately after towel drying

    - at least every 2 hours

    - limit time in the sun, especially from 10 a.m. – 2 p.m.
    - wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

AQUA/WATER/EAU, CAPRYLYL METHICONE, CYCLOPENTASILOXANE, GLYCERIN, TITANIUM DIOXIDE, MICA, PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER, BUTYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, ISOPROPYL MYRISTATE, BIS-PEG/PPG-14/14 DIMETHICONE, XYLITYLGLUCOSIDE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, IRON OXIDES, ANHYDROXYLITOL, CYCLOHEXASILOXANE, ALUMINUM STARCH OCTENYLSUCCINATE, SODIUM CHLORIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PROPYLENE GLYCOL, ALOE BARBADENSIS
LEAF JUICE, SUCROSE DILAURATE, XYLITOL, DIAZOLIDINYL UREA, SODIUM BENZOATE, HYDROLYZED PRUNUS DOMESTICA, PROPYLENE CARBONATE, POTASSIUM SORBATE, CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT, GLUCOSE, PHENOXYETHANOL, POLYSORBATE 20, TOCOPHERYL ACETATE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, PISUM SATIVUM (PEA) EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT, CAMELLIA OLEIFERA LEAF EXTRACT, ISOCETETH-10, CAPRYLYL GLYCOL, HYDROLYZED WHEAT PROTEIN, P-ANISIC ACID, ETHYLHEXYLGLYCERIN, SORBIC ACID, IODOPROPYNYL BUTYLCARBAMATE, CITRIC ACID, COLLOIDAL GOLD.

Other information

Questions or comments?

Call toll free 1-800-387-7710

Principal Display Panel - 7 mL 0.23 Fl.Oz.

Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35

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MARCELLE CC CREAM COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 35 
octinoxate and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69922-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.525 g  in 7 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.21 g  in 7 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SUCROSE DILAURATE (UNII: 5926LC4S7M)  
XYLITOL (UNII: VCQ006KQ1E)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CHICORY ROOT (UNII: 090CTY533N)  
DEXTROSE (UNII: IY9XDZ35W2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PEA (UNII: W4X7H8GYFM)  
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
ISOCETETH-10 (UNII: 1K92T9919H)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SORBIC ACID (UNII: X045WJ989B)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GOLD (UNII: 79Y1949PYO)  
Product Characteristics
Colorbrown (Tinted Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69922-003-011 in 1 CARTON06/01/2017
17 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2017
Labeler - Groupe Marcelle Inc. (202309647)

Revised: 6/2018
Document Id: dfa6f7d5-5b32-4228-94ff-6ce5ac3cc3a3
Set id: 47077eff-fb03-4e76-b1ac-c97275272230
Version: 1
Effective Time: 20180613
 
Groupe Marcelle Inc.