Label: SKIN CRAVE BROAD SPECTRUM SPF30- spf30 broad spectrum sunscreen lotion lotion

  • 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 December 5, 2014

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  • DOSAGE & ADMINISTRATION

    Directions: Apply liberally and evenly 15 minutes before sun exposure.

    Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immediately after towel drying.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Polyester-7, Neopentyl Glycol Diheptanoate, Triethanolamine, Hypromellose, Acrylic Polymer, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn. If used as direted with other sun protection measures, decreases the risk of skin cancer and eraly aging caused by the sun.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    WARNINGS:

    For external use only.

    When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove.

    Stop use and ask a doctor if irritation or rash develops and persists.

    Keep out of reach of children. If products is swalled, seek immediate medical attention or contact a Poison Control Center right away.

  • ACTIVE INGREDIENT

    Active Ingredients:

    Octocrylene 10%

    Homosalate 10%

    Oxybenzone 6%

    Octisalate 5%

    Avobenzone 3%

  • PRINCIPAL DISPLAY PANEL

    PLPDP

  • INGREDIENTS AND APPEARANCE
    SKIN CRAVE BROAD SPECTRUM SPF30 
    spf30 broad spectrum sunscreen lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-224-1010 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2012
    2NDC:58418-224-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2012
    3NDC:58418-224-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2012
    4NDC:58418-224-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2012
    5NDC:58418-224-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    6NDC:58418-224-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    7NDC:58418-224-283840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    8NDC:58418-224-08240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2012
    Labeler - Tropical Enterprises International Inc (091986179)
    Registrant - Tropical Enterprises International Inc (091986179)
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