NDC | 49967-578-01, 49967-578-02, 49967-578-03, 49967-578-04 |
Set ID | 356b8e9a-bd6e-47a8-898c-21cf003c46b9 |
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
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
For sunscreen use:
● shake well
● 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 or 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
-
Inactive ingredients
water, glycerin, alcohol denat., dicaprylyl ether, polyglyceryl-4 isostearate, ascorbyl glucoside, silica, nylon-12, tribehenin, disteardimonium hectorite, butylene glycol, rosa canina fruit oil, PEG-30 dipolyhydroxystearate, saccharomyces/xylinum/black tea ferment, sodium chloride, aluminum hydroxide, adenosine, disodium stearoyl glutamate, butyrospermum parkii (shea butter) seedcake extract, phenoxyethanol, fragrance, linalool, geraniol, limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, citronellol, butylphenyl methylpropional, hexyl cinnamal, benzyl alcohol; may contain: titanium dioxide, iron oxides
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LANCOME PARIS CITY MIRACLE BROAD SPECTRUM SPF 50 SUNSCREEN CC
homosalate, octisalate, octocrylene and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-578 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 16 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) DICAPRYLYL ETHER (UNII: 77JZM5516Z) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) TRIBEHENIN (UNII: 8OC9U7TQZ0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ADENOSINE (UNII: K72T3FS567) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) LINALOOL, (+/-)- (UNII: D81QY6I88E) GERANIOL (UNII: L837108USY) LIMONENE, (+)- (UNII: GFD7C86Q1W) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-578-01 1 in 1 CARTON 01/01/2015 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-578-02 1 in 1 CARTON 01/01/2015 2 10 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49967-578-03 1 in 1 CARTON 01/01/2015 3 5 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:49967-578-04 1 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2015 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations SICOS ET CIE 276993581 manufacture(49967-578)