MARCELLE CC CREAM COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate and oxybenzone cream

Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35 by

Drug Labeling and Warnings

Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35 by is a Otc medication manufactured, distributed, or labeled by Groupe Marcelle Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

PURPOSE

Active Ingredients    Purpose

Octinoxate 7.5%         Sunscreen

Oxybenzone 3.0%       Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• apply liberally 15 minutes before sun exposure
• reapply:

    - after 40 minutes of swimming or sweating

    - immediately after towel drying

    - at least every 2 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 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 sunglasses

•  Children under 6 months: Ask a doctor

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

• protect this product from excessive heat and direct sun   

Questions or comments?

Call toll free 1-800-387-7710

Principal Display Panel - 30 mL 1.1 Fl.Oz.

Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF

INGREDIENTS AND APPEARANCE

MARCELLE CC CREAM COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 35 
octinoxate and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69922-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 g  in 30 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.9 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown (Tinted Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69922-001-01	1 in 1 CARTON	04/01/2016
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 69922-001-02	7 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2016

Labeler - Groupe Marcelle Inc. (202309647)