Label: THE CELLIN SC BB CREAM SPF 25 PA- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76173-1100-1, 76173-1100-2 - 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 August 28, 2013
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
Titanium Dioxide 6.39%
Octinoxate 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
■ Apply generously and evenly 15-20 minutes before sun exposure.
■ Use a water resistant sunscreen if swimming or sweating.
■ Reapply every 1-2 hours after towel drying, swimming or perspiring.
■ 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 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-sleeve shirts, pants, hats, and sunglasses
■ 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 external 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 lastsDosage & Administration
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.Inactive Ingredient
WATER, CYCLOPENTASILOXANE, GLYCERIN, CYCLOMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, TALC, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE, ISOPROPYL ISOSTEARATE, NIACINAMIDE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, PORTULACA OLERACEA EXTRACT, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, C12-14 PARETH-3, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, PHENOXYETHANOL, DIMETHICONE, METHICONE, PALMITIC ACID, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, ADENOSINE, SODIUM HYALURONATE, SOLUBLE COLLAGEN, FULLERENES, HUMAN ADIPOCYTE CONDITIONED MEDIA EXTRACT, ARCTIUM LAPPA ROOT EXTRACT, PHELLINUS LINTEUS EXTRACT, BUTYLENE GLYCOL, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, DEFINED CELL CULTURE MEDIA 2, GLYCINE SOJA (SOYBEAN) SPROUT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, PUERARIA THUNBERGIANA ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, ALOE BARBADENSIS LEAF JUICE, 1,2-HEXANEDIOL, GLYCERYLAMIDOETHYL METHACRYLATE/STEARYL METHACRYLATE COPOLYMER, XANTHAN GUM, CARBOMER, POLYSORBATE 20, METHYLINOSITOL, ASCORBYL HYALURONATE, PALMITOYL DIPEPTIDE-17, PALMITOYL PENTAPEPTIDE-4, CI 77492, CI 77499, CI 77491, FRAGRANCE
- The Cellin SC BB Cream SPF25 PA
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INGREDIENTS AND APPEARANCE
THE CELLIN SC BB CREAM SPF 25 PA
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76173-1100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.39 g in 30 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.00 g in 30 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.92 g in 30 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE (UNII: NMQ347994Z) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TALC (UNII: 7SEV7J4R1U) HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE (UNII: 1959TW0O9A) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) NIACINAMIDE (UNII: 25X51I8RD4) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM SULFATE (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PURSLANE (UNII: M6S840WXG5) C12-14 PARETH-3 (UNII: 93RY22U87E) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) METHICONE (20 CST) (UNII: 6777U11MKT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PALMITIC ACID (UNII: 2V16EO95H1) FERRIC OXIDE RED (UNII: 1K09F3G675) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ADENOSINE (UNII: K72T3FS567) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUCKMINSTERFULLERENE (UNII: NP9U26B839) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CHAMOMILE (UNII: FGL3685T2X) SOYBEAN (UNII: L7HT8F1ZOD) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) ALOE VERA LEAF (UNII: ZY81Z83H0X) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) XANTHAN GUM (UNII: TTV12P4NEE) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLINOSITOL (UNII: TF9HZN9T0M) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) Product Characteristics Color white (black) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76173-1100-2 1 in 1 BOX 1 NDC:76173-1100-1 30 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/28/2013 Labeler - Cellinbio Co Ltd (557803737) Registrant - Cellinbio Co Ltd (557803737) Establishment Name Address ID/FEI Business Operations Cellinbio Co Ltd 557803737 relabel(76173-1100) Establishment Name Address ID/FEI Business Operations KOLMAR KOREA CO LTD 687846360 manufacture(76173-1100)
