Active Ingredients
Ethylhexyl Methoxycinnamate (6%)
Titanium Dioxide (4.044%)
Ethylhexyl Salicylate (2%)
Zinc Oxide (1.92%)
Intensive Cover Blemish Balm
FDA Label NDC 52554-1113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cms Lab Inc. for the product Intensive Cover Blemish Balm (NDC 52554-1113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, intensive cover blemish balm, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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