Label: INTENSIVE COVER BLEMISH BALM- ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52554-1113-1, 52554-1113-2 - 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 November 11, 2017
If you are a consumer or patient please visit this version.
- 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
- Directions
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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
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INGREDIENTS AND APPEARANCE
INTENSIVE COVER BLEMISH BALM
ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate, zinc oxide creamProduct 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)
