Label: SUNNYLIFE SPF 50 SUNSCREEN FRAGRANCE FREE- avobenzone, homosalate, octisalate, octocrylene 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 November 8, 2018

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  • DRUG FACTS

  • ACTIVE INGREDIENTS:

    Avobenzone 3%, Homosalate 10%

    Ocitsalate 5% Octocrylene 8%

    PURPOSE

    Sunscreen

  • Uses:

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.
  • 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.

    Stop use and ask doctor 

       if rash occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help contact Poison Control Center right away.

  • DIRECTION:

    • For sunscreen use
    • Apply generously 15 minutes before sun exposure. Reapply: 
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying 
    • At least every 2 hours. Skin Protection Measures. Spending time in the sun increases your risk of skin cancer & early sking aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher & other sun protection measures including:
    • Limit time in the sun, especially from 10am-2pm
    • Wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months: ask a doctor.
  • OTHER INFORMATION:

    Protect this product from excessive heat and direct sun.

  • INACTIVE INGREDIENTS:

    Water, Cera Alba, C12-15 Alkyl Benzoate, SIlica, PEG-15 Cocamine, PEG-40 Stearate, Carbomer, Hydroxyethylcellulose, Caprylhydroxamic Acid, Caprylyl Glycol, Glycerin, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Citric Acid.

  • QUESTIONS OR COMMENTS?

    +1 323.591.0219

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SUNNYLIFE SPF 50 SUNSCREEN FRAGRANCE FREE 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72566-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PEG-15 COCAMINE (UNII: 8L6LB12TSJ)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72566-050-06200 mL in 1 BOTTLE; Type 0: Not a Combination Product01/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/06/2019
    Labeler - OUTLIVING PTY LTD (745474788)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Laboratories Pty. Ltd.740537709manufacture(72566-050)
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