Label: CELL FUSION C LASER SUNSCREEN- zinc oxide, homosalate, octisalate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52554-1200-1, 52554-1200-2 - Packager: CMS LAB Inc.
- 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 May 4, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
Directions
For sunscreen use:
■ 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 you 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 10a.m.-2p.m.
■ wear long-sleeved shirts, pants, hats, and sunglasses
■ children under 6 months of age : Ask a doctor -
Inactive ingredients
Inactive ingredients
Water, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Butyloctyl Salicylate, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, 1,2-Hexanediol, Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Lavandula Angustifolia (Lavender) Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Sodium Citrate, Hydroxydecyl Ubiquinone,
Hydrolyzed Collagen, Tocopherol, Hydrogenated Lecithin, Ceramide Np, Sucrose Stearate, Cholesterol, Cholesteryl Macadamiate, Palmitic Acid,
Biosaccharide Gum-4, Saccharide Isomerate, Hydrolyzed Lupine Protein - Other Information
- Questions
- Package Label: Cell Fusion C Laser Sunscreen SPF50+ 10mL
- Package Label: Cell Fusion C Laser Sunscreen SPF50+ 50mL
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INGREDIENTS AND APPEARANCE
CELL FUSION C LASER SUNSCREEN
zinc oxide, homosalate, octisalate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52554-1200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 12.70 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.50 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.50 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.20 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Dipropylene Glycol (UNII: E107L85C40) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) Glycerin (UNII: PDC6A3C0OX) Butyloctyl Salicylate (UNII: 2EH13UN8D3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) 1,2-Hexanediol (UNII: TR046Y3K1G) Triethoxycaprylylsilane (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q) Lavender Oil (UNII: ZBP1YXW0H8) Glyceryl Caprylate (UNII: TM2TZD4G4A) Sodium Citrate (UNII: 1Q73Q2JULR) IDEBENONE (UNII: HB6PN45W4J) Tocopherol (UNII: R0ZB2556P8) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) Ceramide Np (UNII: 4370DF050B) Sucrose Stearate (UNII: 274KW0O50M) Cholesterol (UNII: 97C5T2UQ7J) Cholesteryl Macadamiate (UNII: DFP79OD7KP) Palmitic Acid (UNII: 2V16EO95H1) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) Saccharide Isomerate (UNII: W8K377W98I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52554-1200-1 10 mL in 1 CARTON; Type 0: Not a Combination Product 05/01/2020 2 NDC:52554-1200-2 50 mL in 1 CARTON; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2020 Labeler - CMS LAB Inc. (557795012) Registrant - CMS LAB Inc. (557795012) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co.,LTD. Gwanjeong Factory 689512611 manufacture(52554-1200)
