EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [BIOCOSMETICA EXEL ARGENTINA SRL]

EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [BIOCOSMETICA EXEL ARGENTINA SRL]
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NDC 67623-001-01, 67623-001-02
Set ID e65a68f6-d1b7-4cbf-a3f8-5cc04036221a
Category HUMAN OTC DRUG LABEL
Packager Biocosmetica Exel Argentina SRL
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient ........ Purpose

    Octinoxate 7.5% ........ Sunscreen
    Octocrylene 8% ........ Sunscreen

    Oxybenzone 3% ........ Sunscreen

    Titanium Dioxide 5% ........ Sunscreen

  • PURPOSE

    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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS AND PRECAUTIONS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    - Apply liberally 15 minutes before sun exposure

    - Reapply at least every 2 hours

    - Children under 6 month: ask a doctor

    -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 including:

    Limit time in the sun, Especially from 10 AM - 2 PMWear long-sleeved shirts, pants, hats, and sunglassesUse a water resistant sunscreen if swimming or sweating

  • INACTIVE INGREDIENT

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermum Parkii (shea butter) Extract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetearyl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethlyamino Hydroxybenzoyl Hexyl Benzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (witch hazel) Extract, Iron Oxides (C.I. 77497/77492/77499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (saccharomyces cerevisiae extract)  

  • PRINCIPAL DISPLAY PANEL

    Exel Clarifying Line
    SPF 50
    Broad Spectrum SPF 50

    3.30 fl.oz / 100 ml

    Clarifying line label update

  • INGREDIENTS AND APPEARANCE
    EXEL CLARIFYING LINE  SPF 50
    octinoxate, octocrylene, oxybenzone, tatanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67623-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SHEANUT OIL (UNII: O88E196QRF)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ECTOINE (UNII: 7GXZ3858RY)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67623-001-021 in 1 PACKAGE05/14/2015
    1NDC:67623-001-01100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/14/2015
    Labeler - Biocosmetica Exel Argentina SRL (971813332)
    Registrant - Biocosmetica Exel Argentina SRL (971813332)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biocosmetica Exel Argentina SRL971813332manufacture(67623-001)

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