NDC | 49967-445-01, 49967-445-02 |
Set ID | 7ad06ec1-9c11-4b97-8a44-d4866fd5b523 |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 of higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
water, dicaprylyl ether, glycerin, alcohol denat., polyglyceryl-4 isostearate, ascorbyl glucoside, silica, nylon-12, disteardimonium hectorite, tirbehenin, PEG-30 dipolyhydroxystearate, sodium chloride, phenoxyethanol, disodium stearoyl glutamate, adenosine, aluminum hydroxide; may contain: titanium dioxide, iron oxides
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SKIN TONE CORRECTING AND BEAUTIFYING BB SUNSCREEN
homosalate, octisalate, octocrylene and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-445 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIBEHENIN (UNII: 8OC9U7TQZ0) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ADENOSINE (UNII: K72T3FS567) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-445-01 1 in 1 CARTON 03/01/2013 1 40 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-445-02 3 mL in 1 PACKET; Type 0: Not a Combination Product 03/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2013 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising Inc. 076693183 manufacture(49967-445) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-445)