Label: CROC BLOC SPF 30 FPS ECRAN SOLAIRE- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene liquid spray sunscreen liquid

  • 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 May 26, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Octinoxate

    7.5% w/w

    Sunscreen

    Octisalate

    4.0% w/w

    Sunscreen

    Oxybenzone

    4.0% w/w

    Sunscreen

    Avobenzone

    2.0% w/w

    Sunscreen

    Octocylene

    1.5% w/w

    Sunscreen

    Active Ingredients

    Purposes

    Octinoxate

    7.5% w/w

    Sunscreen

    Octisalate

    4.0% w/w

    Sunscreen

    Oxybenzone

    4.0% w/w

    Sunscreen

    Avobenzone

    2.0% w/w

    Sunscreen

    Octocylene

    1.5% w/w

    Sunscreen

  • Warnings

    For external use only

    May stain or damage some fabrics or surfaces.

  • DO NOT USE

    on damaged or broken skin

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    Avoid contact with eyes. Rinse with water to remove.

  • STOP USE

    Rash and irritation develops and lasts

  • Directions

    Apply liberally and evenly to dry skin 15 minutes belofe going Into the sun. Reapply at least fN8ry 2 houlS. Reapply after 80 minutes of swimming or sweating. Reapply lmmetlatety after towel drying.
    • For children under 6 months of age: Ask a doctor

  • Other Information

    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 value of 15 or higher and other sun protection measures inciucling: limit time In the sun, especially from 10 a.m.-2 p.m.; and Wear long-sleeved shirts, pants, hats, and sunglasses. lf used as directed with
    other sun protection measures (See Dlrections), decreases the risk of skin cancer and early skin aging caused by the sun. Protect container from freezing.

  • INACTIVE INGREDIENT

    Aqua, Aloe Barbadensis Leaf Exlract, lsododecane, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Methyl Glucose Sesquistearate, PEG-20 Methyl Glucose Sesquistearate, Polyester-8. PVP/Hexadecene Copolymer, Tocopheryl Acetate, Decyl Glucoside. Stearyl Alcohol, Ceteareth-20, Microcrystalline Cellulose, Cellulose Gum, Propylene Glycol, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben.

  • PRINCIPAL DISPLAY PANEL

    Liquid Spray

    Sunscreen

    SPF 30 FPS

    Ecran solaire

    en vaporisateur

    liquide

    BROAD SPECTRUM • LARGE SPECTRE

    UVA/UVB PROTECTION

    CONTRE LES RAYONS UVA ET UVB

    Hypoallergic • Moisturizing Aloe & Vitamin E

    Unscented • Water Resistant (80 minutes)

    Hypoallergenique • Hydratante avec Vitamine E et Aloes

    Non Parfumee • Resiste a l'eau

    Principal panel

  • INGREDIENTS AND APPEARANCE
    CROC BLOC SPF 30 FPS ECRAN SOLAIRE 
    octinoxate, octisalate, oxybenzone, avobenzone, octocrylene liquid spray sunscreen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58331-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58331-301-01180 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/28/2020
    Labeler - Degil Safety Products (1989) Inc. (247083686)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies Inc.171837367manufacture(58331-301)