LASER SUNSCREEN 100- octisalate, octinoxate, zinc oxide, titanium dioxide cream

Laser Sunscreen 100 by

Drug Labeling and Warnings

Laser Sunscreen 100 by is a Otc medication manufactured, distributed, or labeled by CMS LAB Inc., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LASER SUNSCREEN 100 
octisalate, octinoxate, zinc oxide, titanium dioxide cream

Product 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)