Label: THE CELLIN EOP B.B CREAM- titanium dioxide, octinoxate, zinc oxide emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 76173-1004-1, 76173-1004-2 - Packager: Cellinbio Co Ltd
- 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 July 27, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Drug Facts
Active ingredient
Titanium Dioxide 6.39%
Ethylhexyl Methoxycinnamate 3.00%
Zinc Oxide 1.92%Keep out of Reach of Children
Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.
Indication & Usage
Directions
After finishing your basic skincare, apply an appropriate amount of this cream all around the face
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours(when used as sunscreen)
Children under 6 months: Ask a doctorWarnings
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging
For extenal use only
Do not use on damaged or broken skin. If sun irritation develops or increases.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash or irritation develops and lastsInactive Ingredient
Water, Cyclopentasiloxane, Glycerin, Cyclomethicone, Dipropylene Glycol, Peg-10 Dimethicone, Talc, Arbutin, Hexyldecyl Myristoyl Methylaminopropionate, Isopropyl Isostearate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Disteardimonium Hectorite, Magnesium Sulfate, Iron Oxides(CI 77492), Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, C12-14 Pareth-3, Portulaca Oleracea Extract, Silica, Dimethicone/Vinyl Dimethicone crosspolymer, Phenoxyethanol, Methicone, Iron Oxides(CI 77499), Palmitic Acid, Iron Oxides(CI 77491), Aluminum Hydroxide, Dimethicone, Aluminum Stearate, Ethylhexylglycerin, Fragrance, Tocopheryl Acetate, Sodium Hyaluronate, Human Adipocyte Conditioned Media Extract, Adenosine, Madecassoside, Niacinamide
- The Cellin EOP B.B Cream
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INGREDIENTS AND APPEARANCE
THE CELLIN EOP B.B CREAM
titanium dioxide, octinoxate, zinc oxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76173-1004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.556 mL in 40 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.2 mL in 40 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.768 mL in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE (UNII: NMQ347994Z) DIPROPYLENE GLYCOL (UNII: E107L85C40) TALC (UNII: 7SEV7J4R1U) ARBUTIN (UNII: C5INA23HXF) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PALMITIC ACID (UNII: 2V16EO95H1) FERRIC OXIDE RED (UNII: 1K09F3G675) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ADENOSINE (UNII: K72T3FS567) NIACINAMIDE (UNII: 25X51I8RD4) Product Characteristics Color black (gold) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76173-1004-2 1 in 1 BOX 1 NDC:76173-1004-1 40 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/27/2011 Labeler - Cellinbio Co Ltd (557803737) Registrant - Cellinbio Co Ltd (557803737) Establishment Name Address ID/FEI Business Operations Cellinbio Co Ltd 557803737 relabel Establishment Name Address ID/FEI Business Operations KOLMAR KOREA CO LTD 687846360 manufacture