SURFERS SKIN SUNSCREEN LIP BALM (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) STICK [SKIN ALIVE, LTD.]

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SURFERS SKIN SUNSCREEN LIP BALM (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) STICK [SKIN ALIVE, LTD.]
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NDC 75916-0660-8
Set ID d49062c4-90b1-4db5-b616-1971fa628346
Category HUMAN OTC DRUG LABEL
Packager Skin Alive, Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredients

    Avobenzone 2.5%
    Octinoxate 7.5%
    Octocrylene 5.0%
  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    Helps prevent sunburn

    Higher SPF gives more sunburn protection

    Provides high protection against sunburn

    Regains SPF after 80 minutes of sweating.

  • WARNINGS

    Warnings

    For external use only

    UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.


  • WHEN USING

    When using this product

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor

    if irritation occurs or rash develops ad lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions
    Apply generously 15 mins before sun exposure and as needed
    Children under 6 months of age; ask a doctor
    Reapply as needed or after towel drying, swimming or sweating.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip

  • DESCRIPTION

    Surfers Skin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera


    To report a serious adverse event, contact 1-800-332-1088

    Expires:

    Lot Number:

    www.surfersskin.co

    DIST. BY Quiver Dist, Bend Oregon, USA 97701

    AS/ANZ STANDARD 2604-1998

    Tested on Sursfers - Not Animals

    Net Wt. .3oz (8.5g)

  • PRINCIPAL DISPLAY PANEL

    SPF 30+

    very water / sweat resistant

    broad spectrum

    UVA/UVB protection



    Proven in extreme New Zealand conditions

    Surfers Skin sunscreen lip balm


    Net Wt. .30 oz (8.5g)

    contains no nanoparticles - aminobenzoic acid (PABA)-free

  • PRINCIPAL DISPLAY PANEL

    Surfers Skin Lip Balm

  • PRINCIPAL DISPLAY PANEL

    Surfer Skin Sunscreen

  • INGREDIENTS AND APPEARANCE
    SURFERS SKIN SUNSCREEN LIP BALM 
    avobenzone, octinoxate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-0660
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75916-0660-81 in 1 BOX
    18.5 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/17/2011
    Labeler - Skin Alive, Ltd. (593384746)
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