Label: LASER SUNSCREEN 100- octisalate, octinoxate, zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52554-1115-1, 52554-1115-2 - 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 January 29, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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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 help prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use when skin is red, inflamed, irritated, or painful
When using this product
- do not apply on other parts of the body
- do not use on damaged or broken skin
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut
Stop use and ask a doctor if
- Rash or irritation on skin develops and lasts
- Keep out of reach of children
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Directions
- Apply the adequate amount onto the entire face at the last stage of your skin care routine. Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips.
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
- Children under 6 months of age: ask a doctor
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Inactive ingredients
WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, DICAPRYLYL CARBONATE, PEG-10 DIMETHICONE, LAURYL PEG-8 DIMETHICONE, DIMETHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, PHENYL TRIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, METHICONE, POLYGLYCERYL-6 POLYRICINOLEATE, CAPRYLYL GLYCOL, FRAGRANCE, GLYCERYL CAPRYLATE, TOCOPHERYL ACETATE, DISODIUM EDTA, HYDROLYZED COLLAGEN, UBIQUINONE, ACETYL HEXAPEPTIDE-8
- Laser Sunscreen 100
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INGREDIENTS AND APPEARANCE
LASER SUNSCREEN 100
octisalate, octinoxate, zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52554-1115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.75 g in 35 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.68 g in 35 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.8715 g in 35 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.625 g in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIPROPYLENE GLYCOL (UNII: E107L85C40) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52554-1115-2 1 in 1 PACKAGE 01/16/2018 1 NDC:52554-1115-1 35 mL in 1 TUBE; 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 01/16/2018 Labeler - CMS LAB Inc. (557795012) Registrant - CMS LAB Inc. (557795012) Establishment Name Address ID/FEI Business Operations CMS LAB Inc. 557795012 relabel(52554-1115) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(52554-1115)
