LASER SUNSCREEN 100- octisalate, octinoxate, zinc oxide, titanium dioxide cream 
CMS LAB Inc.

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.

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Laser Sunscreen 100

Active ingredients

Octinoxate (7.5%)

Octisalate (5%)

Zinc Oxide (4.8%)

Titanium Dioxide (2.49%)

Purpose

Sunscreen

Uses

Helps prevent sunburn

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

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

laser sunscreen 100

LASER SUNSCREEN 100 
octisalate, octinoxate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.75 g  in 35 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.68 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.8715 g  in 35 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.625 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52554-1115-21 in 1 PACKAGE01/16/2018
1NDC:52554-1115-135 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/16/2018
Labeler - CMS LAB Inc. (557795012)
Registrant - CMS LAB Inc. (557795012)
Establishment
NameAddressID/FEIBusiness Operations
CMS LAB Inc.557795012relabel(52554-1115)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(52554-1115)

Revised: 1/2018
Document Id: 63f41ca6-6c48-394c-e053-2991aa0a2b03
Set id: 62ede81a-ab15-8e88-e053-2991aa0aa069
Version: 4
Effective Time: 20180129
 
CMS LAB Inc.