Label: CICATRICURE BRIGHTENING FACE WITH SPF- avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL

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 February 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE, 7.5%Sunscreen
    OCTISALATE, 4.5%Sunscreen
    HOMOSALATE, 4.5%Sunscreen
    OXYBENZONE, 3%Sunscreen
    AVOBENZONE, 1%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 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use

    • apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating.

    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 factor of 15 or higher and other skin protection measures including:

    • limit time in the sun, especially from 10am to 2pm
    • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Other information

    • protect product from excessive heat and direct sun
    • may stain some fabrics
    • keep this carton for future reference.
  • Inactive ingredients

    WATER, GLYCERIN, ALCOHOL, POLYSORBATE 60, SORBITAN STEARATE, BUTYLENE GLYCOL, TRIETHANOLAMINE, CARBOMER, BENZYL ALCOHOL, PHENOXYETHANOL, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, FRAGRANCE, POLYSORBATE 20, HYDROLYZED OAT PROTEIN, PPG-2 MYRISTYL ETHER PROPIONATE, ETHYL ASCORBIC ACID, ALPHA-ARBUTIN, ETHYLHEXYLGLYCERIN, SILANEDIOL SALICYLATE, MELANIN, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7.

  • Questions

    Call toll free 1 877-994-3666 Monday to Friday, 8am to 6pm, Central time

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA Inc.
    Houston, TX 77098

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

    WITH SUNSCREEN

    cicatricure®
    BRIGHTENING CREAM

    Unifies skin tone

    Reduces appearance
    of wrinkles

    Moisturizes and helps nourish

    EXCLUSIVE FORMULA *QACETYL 10®
    & NUTRI-ACLARANT

    SPF 20

    *QAcetyl-10® is an exclusive blend of conditioners and peptides

    Net. Wt. 1.6 FL Oz (50 ml)

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CICATRICURE BRIGHTENING FACE WITH SPF 
    avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone10 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate45 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate45 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    glycerin (UNII: PDC6A3C0OX)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Butylene glycol (UNII: 3XUS85K0RA)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-704-011 in 1 CARTON10/07/2019
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/07/2019
    Labeler - Genomma Lab USA (832323534)
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