Label: SCAR CREAM SPF 30- avobenzone, octocrylene, oxybenzone cream

  • 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 January 22, 2019

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  • Active Ingredients

    Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    For external use only.

    Skin Cancer/Skin Aging Alert: spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer and early skin aging.

    Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes 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

    Apply generously and evenly 15 minutes before sun exposure. Reapply:

    • at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating

    Children under 6 months: ask a doctor.

  • Inactive Ingredients

    Water, Allium Cepa (Onion) Bulb Extract, Sorbitan Isostearate, Sorbitol, Polyester-7, VP/Eicosene Copolymer, Glyceryl Caprylate, decolorized Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Lepidium Sativum (Cress) Sprout Extract, Allantoin, Tocopherol, Stearic Acid, Polysorbate 80, Carbomer, Dimethicone, Disodium EDTA, Lecithin, Glycerin, Neopentyl Glycol Diheptanoate, Polyglyceryl-3 Distearate, Benzyl Alcohol, Triethanolamine, Phenoxyethanol

  • Label

    Carton

  • INGREDIENTS AND APPEARANCE
    SCAR CREAM SPF 30 
    avobenzone, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    MATRICARIA RECUTITA LEAF (UNII: 6I9LN466F0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    WATER (UNII: 059QF0KO0R)  
    ONION (UNII: 492225Q21H)  
    SORBITOL (UNII: 506T60A25R)  
    POLYESTER-7 (UNII: 0841698D2F)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-019-011 in 1 CARTON01/07/2019
    119.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/07/2019
    Labeler - Genomma Lab (832323534)
    Registrant - CGI Packaging, LLC (080691099)
    Establishment
    NameAddressID/FEIBusiness Operations
    CGI Packaging, LLC080691099manufacture(50066-019)
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