Label: PRO-TECT EVERYDAY SUNSCREEN SPF 15- octinoxate, octisalate, padimate o lotion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 9, 2015

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  • DRUG FACTS

    Pro-Tect® SPF 15+ Sunscreen Broad-Spectrum UVA/UVB Protection & Moisturizing Lotion

  • Active Ingredients

    Octinoxate...........................................................7.5%

    Oxybenzone.........................................................2.0%

    Padimate O...........................................................5.0%

  • Purpose

    Sunscreen

  • Uses

    •Pro-Tect® SPF 15+ Broad-Spectrum UVA & UVB protection. •Helps prevent sunburn. •Retains a SPF of 15+ after 80 minutes of activity in water of perspiring. •Provides high protection against sunburn and tanning. •For skin highly sensitive to sunburn.

  • Warnings

    •External use only. •When using this product, keep out of eyes. •Rinse with water to remove. •Stop use and ask a doctor if rash or irritation develops and lasts. •Do not use if sensitive to any of the ingredients of their related compounds.

  • KEEP OUT OF REACH OF CHILDREN

    ​KEEP OUT OF REACH OF CHILDREN

  • Directions

    •Apply liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed. •Children under 6 months of age: ask a doctor.

  • Inactive Ingredients

    Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Trolamine, Water.

  • Other Information

    •Daily usage of Pro-Tect SPF15+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. •This product provides more than 15 times your natural protection against sunburn. •Very Water Resistant UVA & UVB Broad-Spectrum Protection. •This product may stain light colored fabrics if washed with bleach. Wash clothing without bleach to remove safely.

  • Questions or Comments

    Bio-Medical & Pharm. Mfg. Corp.

    4311 South Dr.

    Houston, TX 77053-4820

    281-835-8051

    M-F 8AM-5PM

    www.bio-medicalmanufacturing.com

  • Principal Display Panel - Pro-Tect Everyday Sunscreen SPF 15 190 grams NDC:37945-868-65

    0e256f99-a3bf-648b-e054-00144ff8d46c.jpg Label

  • INGREDIENTS AND APPEARANCE
    PRO-TECT EVERYDAY SUNSCREEN   SPF 15
    octinoxate, octisalate, padimate o lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-868
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37945-868-06207.7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/198702/05/2015
    2NDC:37945-868-65190 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/1987
    Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-868)
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