Label: ICE SUN BC AIR PUFF- titanium dioxide, octinoxate, zinc oxide, octisalate liquid

  • 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 28, 2016

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Titanium Dioxide (2.8%)

    Octinoxate (Ethylhexyl Methoxycinnamate) (2.1%)

    Zinc Oxide (1.6%)

    Octisalate (Ethylhexyl Salicylate) (1.4%)

  • Purpose

    Sunscreen

  • Keep out of reach of children

    Do not swallow. In case of accidental ingestion, seek professional assistance

  • Warnings

    For external use only
    Do not use on damaged or broken skin
    Do not store at any high or low temperature or sunlight. Product uses high pressure gas and flammable.
    Shake well before use
    Do not spray over 3 second on same place, face, must use on hand and then spread it on face
    If possible spray the product from 20cm or farther from body
    Do not inhale spray gas
    When using this product
     Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
     Do not use near fire, heating device, in room that uses flammable device such as heater
     Do not store product over 104°F (40°C), and in enclosed place
     Do not dispose in to incinerator
     Before dispose gas must be removed
    Stop use and ask doctor if rash or irritation on skin develops and lasts.

    Store at room temperature
    Before use, Shake well.
    After Use, lid must be sealed in enclosed place, must ventilate room.

  • Uses

    Helps prevent sunburn

  • Directions

    • Turn bottle lid to “ON” state. Shake the bottle well, pump it 4-5 times and take out the puff and apply it on skin.
    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
     Limit time in the sun, especially from 10 a.m. - 2 p.m.
     Wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months of age: ask a doctor

  • Inactive Ingredients

    Butane, Propane, Water, Cyclopentasiloxane, Alcohol Denat., Propanediol, Bis-Ethylhexyloxyphenol methoxyphenyl triazine, C13-15 Alkane, Niacinamide, Lauryl PEG-9 polydimethylsiloxyethyl dimethicone, Aluminum Hydroxide, Stearic Acid, 1,2-Hexanediol, Lauryl PEG-8 Dimethicone, Polyglyceryl-6 Polyricinoleate, Hydrogen Dimethicone, Parfum, Talc, CI 77492, Polymethyl Methacrylate, Butylene Glycol, CI 77491, Adenosine, Hamamelis Virginiana (Witch Hazel) Water, Disodium EDTA, Alcohol, CI 77499, Ultramarines, Sodium hyaluronate, Glycerin, Triethoxycaprylylsilane, Epilobium Angustifolium Flower/Leaf/Stem Extract, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Lilium Tigrinum Extract, Phenoxyethanol, Camellia Japonica Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Sodium Hydroxide, Sodium Metabisulfite, Ethylhexylglycerin

  • ICE SUN BC AIR PUFF

    ice sun air puff

  • INGREDIENTS AND APPEARANCE
    ICE SUN BC AIR PUFF 
    titanium dioxide, octinoxate, zinc oxide, octisalate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71055-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.8 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butane (UNII: 6LV4FOR43R)  
    Propane (UNII: T75W9911L6)  
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    Niacinamide (UNII: 25X51I8RD4)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Talc (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Adenosine (UNII: K72T3FS567)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALCOHOL (UNII: 3K9958V90M)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    LILIUM LANCIFOLIUM BULB (UNII: 47Z05W73EZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    SAGE (UNII: 065C5D077J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71055-100-021 in 1 PACKAGE10/21/2016
    1NDC:71055-100-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/21/2016
    Labeler - POPCO CO.,LTD. (689851927)
    Registrant - POPCO CO.,LTD. (689851927)
    Establishment
    NameAddressID/FEIBusiness Operations
    POPCO CO.,LTD.689851927manufacture(71055-100)