Label: COCOOIL SPF 30- octocrylene, octinoxate, octisalate, oxybenzone, avobenzone 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 October 31, 2018

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  • Drug Facts

  • Active ingredients

    Octocrylene 8%, Octyl methoxycinnamate 7.5%,
    Octisalate 5%, Oxybenzone 3%, Avobenzone 2.5%

    Purpose

    Sunscreen

  • 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.

  • 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 a doctor

    • if rash occurs

    Keep out of reach of children

    • If this product is swallowed get medical help or contact a Poison Control Centre right away.
  • Directions

    APPLY liberally 15 minutes before sun exposure

    • USE a waterresistant sunscreen if sweating or swimming.

    Sun Protection Measures. SPENDING time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including

    • LIMIT time in the sun especially between 10 am and 2 pm
    • WEAR long sleeved shirts, pants, hats and sunglasses
    • REAPPLY at least every 2 hours
    • USE a water resistant sunscreen if sweating or swimming
    • Children under 6 months ask a doctor.
  • Other information

    • Protect this product from excessive heat and direct sun

  • Inactive ingredients

    CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS SEED OIL, Cold pressed certified organic COCOS NUCIFERA OIL, C12-15 ALKYL BENZOATE, BEESWAX, BUTYROSPERMUM PARKII BUTTER, TRIACONTANYL PVP, PARFUM, TOCOPHEROL

  • Questions?

    Visit www.cocooil.com.au or call +64 9 361 4191

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    COCOOIL SPF 30 
    octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72645-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72645-030-00200 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2018
    Labeler - Cocooil Limited (594933650)
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