INTENSIVE COVER BLEMISH BALM- ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate, zinc oxide cream

Intensive Cover Blemish Balm by

Drug Labeling and Warnings

Intensive Cover Blemish Balm 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

Ethylhexyl Methoxycinnamate (6%)

Titanium Dioxide (4.044%)

Ethylhexyl Salicylate (2%)

Zinc Oxide (1.92%)

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. 

- Apply liberally 15 minutes before sun exposure.

- Use a water-resistant sunscreen if swimming or sweating.

- Children under 6 months of age: ask a doctor

Inactive ingredients

WATER, CYCLOPENTASILOXANE, METHYLPROPANEDIOL, TRIETHOXYCAPRYLYLSILANE, TRIMETHYLSILOXYSILICATE, DIMETHICONE, TRISILOXANE, PHENYL TRIMETHICONE, DIISOSTEARYL MALATE, TALC, METHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TOCOPHEROL, DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, CETYL ETHYLHEXANOATE, DISTEARDIMONIUM HECTORITE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, PALMITIC ACID, TRIHYDROXYSTEARIN, GLYCERYL CAPRYLATE, IRON OXIDES(CI 77499), TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, CHOLESTERYL MACADAMIATE, STEARIC ACID, HYDROLYZED LUPINE PROTEIN, SACCHARIDE ISOMERATE

Intensive Cover Blemish Balm

INGREDIENTS AND APPEARANCE

INTENSIVE COVER BLEMISH BALM 
ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52554-1113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.8 g  in 30 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.2132 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.6 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.576 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TALC (UNII: 7SEV7J4R1U)
METHICONE (20 CST) (UNII: 6777U11MKT)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TOCOPHEROL (UNII: R0ZB2556P8)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52554-1113-2	1 in 1 PACKAGE	11/01/2017
1	NDC: 52554-1113-1	30 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	11/01/2017

Labeler - CMS LAB Inc. (557795012)

Registrant - CMS LAB Inc. (557795012)

Establishment
Name	Address	ID/FEI	Business Operations
CMS LAB Inc.		557795012	relabel(52554-1113)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(52554-1113)