INTENSIVE COVER BLEMISH BALM- ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate, zinc oxide 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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Intensive Cover Blemish Balm

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

intensive cover bb

INTENSIVE COVER BLEMISH BALM 
ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 g  in 30 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.2132 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.6 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.576 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52554-1113-21 in 1 PACKAGE11/01/2017
1NDC:52554-1113-130 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 finalpart35211/01/2017
Labeler - CMS LAB Inc. (557795012)
Registrant - CMS LAB Inc. (557795012)
Establishment
NameAddressID/FEIBusiness Operations
CMS LAB Inc.557795012relabel(52554-1113)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(52554-1113)

Revised: 11/2017
Document Id: a9796d5e-0551-4179-ac75-0b80088ab6b9
Set id: a9838ca8-31cd-430b-94d0-b0ee43222447
Version: 8
Effective Time: 20171111
 
CMS LAB Inc.