FDA.reportPublic FDA data

Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35

Manufacturer
Groupe Marcelle Inc.
Effective date
2021-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:22:34

Label at a glance#

ProductMarcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35
Active ingredientOCTINOXATE, OXYBENZONE
Label structure13 sections

Indications and 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

Dosage and administration

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:     -...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Active Ingredients    Purpose

Octinoxate 7.5%         Sunscreen

Oxybenzone 3.0%       Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun   

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-387-7710

Principal Display Panel - 30 mL 1.1 Fl.Oz.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF

Outer LabelOuter Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69922-001-01Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 3530 mL in 1 BOTTLE, PUMPCREAM303
69922-001-01Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 351 in 1 CARTONCREAM13
69922-001-02Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 357 mL in 1 TUBECREAM73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69922-001MARCELLE CC CREAM COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND OXYBENZONE) CREAM [GROUPE MARCELLE INC.]3Current NDC, Legacy NDC, 3 package rows20241004_c24ac3ad-b2e2-4381-bd80-a499da0e0670.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 54 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69922-00169922-001-01, 69922-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER965K72OQXOIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HEXYL LAURATE4CG9F9W01QIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
BIS-PEG/PPG-14/14 DIMETHICONEX2I70H0QJEIACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
FERRIC OXIDE RED1K09F3G675IACT
ANHYDROXYLITOL8XWR7NN42FIACT
CYCLOMETHICONE 6XHK3U310BAIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
SUCROSE DILAURATE5926LC4S7MIACT
XYLITOLVCQ006KQ1EIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPYLENE CARBONATE8D08K3S51EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CHICORY ROOT090CTY533NIACT
DEXTROSEIY9XDZ35W2IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PEAW4X7H8GYFMIACT
MATRICARIA RECUTITA FLOWERING TOP3VNC7T6Z02IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35OCTINOXATE AND OXYBENZONEGroupe Marcelle Inc.c24ac3ad-b2e2-4381-bd80-a499da0e06702021-12-14WarningsExact identifier
ndc (package): 69922-001-01
ndc (package): 69922-001-02
ndc (product): 69922-001
ndc11 (package): 69922000101
ndc11 (package): 69922000102
spl id: d31dca97-f79f-4bf2-e053-2995a90ac4f6
spl set id: c24ac3ad-b2e2-4381-bd80-a499da0e0670

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.