Marcelle Cc Cream Complete Correction Sunscreen Broad Spectrum Spf 35
FDA Label NDC 69922-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Groupe Marcelle Inc. for the product Marcelle Cc Cream Complete Correction Sunscreen Broad Spectrum Spf 35 (NDC 69922-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - 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.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - 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?

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Principal Display Panel - 30 Ml 1.1 Fl.Oz.

Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF

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