Label: MARCELLE CC CREAM COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate and oxybenzone cream
- NDC Code(s): 69922-003-01
- Packager: Groupe Marcelle Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 13, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
- Questions or comments?
- Principal Display Panel - 7 mL 0.23 Fl.Oz.
-
INGREDIENTS AND APPEARANCE
MARCELLE CC CREAM COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 35
octinoxate and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69922-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.525 g in 7 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.21 g in 7 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:69922-003-01 1 in 1 CARTON 06/01/2017 1 7 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2017 Labeler - Groupe Marcelle Inc. (202309647)
