Label: ICE SUN BC AIR PUFF- titanium dioxide, octinoxate, zinc oxide, octisalate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71055-100-01, 71055-100-02 - Packager: POPCO CO.,LTD.
- Category: HUMAN OTC DRUG LABEL
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
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
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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
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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
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INGREDIENTS AND APPEARANCE
ICE SUN BC AIR PUFF
titanium dioxide, octinoxate, zinc oxide, octisalate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71055-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 2.8 g in 100 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.6 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71055-100-02 1 in 1 PACKAGE 10/21/2016 1 NDC:71055-100-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/21/2016 Labeler - POPCO CO.,LTD. (689851927) Registrant - POPCO CO.,LTD. (689851927) Establishment Name Address ID/FEI Business Operations POPCO CO.,LTD. 689851927 manufacture(71055-100)