Label: PINEAPPLE SPF 30 BROAD SPECTRUM- sunscreen aerosol

  • 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 January 14, 2021

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  • Acitve Ingredients

    Avobenzone 1.9%, Octinoxate 7.1%, Octisalate 3.9%, Octocrylene 6.6%

    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

    Flammable Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 oF.

    For external useonly

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product, keep out of eyes. Rinse with water to remove.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure. Spray on skin and rub for complete and even coverage. Do not spray on face; spray on hands and rub onto face.

    Reapply

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    Children under 6 months: Ask a doctor

    Sun Protection Measure. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen wtih a broad spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10am-2pm
    • Wear long-sleeved shirts, pants, hats and sun glasses
  • Inactive ingredients

    Actinidia Chinensis (Kiwi) Fruit Extract, Alcohol Denat., Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Methyl Dihydroabietate, passiflora Incarnata Extract, Pongamia Glabra Seed Oil, Rubus Idaeus (Raspberry) Fruit Extract

  • Other information

    protect this product from excessive heat and direct sun.

  • PDP

    PDP

  • INGREDIENTS AND APPEARANCE
    PINEAPPLE  SPF 30 BROAD SPECTRUM
    sunscreen aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.9 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.6 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.1 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    ALCOHOL (UNII: 3K9958V90M)  
    RASPBERRY (UNII: 4N14V5R27W)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76150-206-13178 mL in 1 CAN; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2016
    Labeler - Bell International Laboratories, Inc. (967781555)
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