NDC | 49967-583-01, 49967-583-02, 49967-583-03, 49967-583-04 |
Set ID | 26f12077-7b61-4fa2-b754-924a47d796a7 |
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.
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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 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., silica, cyclohexsiloxane, propylene glycol, synthetic fluorphlogopite, cetyl alcohol, dimethicone, stearic acid, palmitic acid, phenoxyethanol, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, fragrance, dimethiconol, zea mays (corn) germ oil, caffeine, tocopherol, disodium EDTA, menthol, limonene, biosacchaide gum-1, sodium hydroxide, ascorbyl glucoside, castanea sativa (chestnut) seed extract, citrus medica limonum (lemon) juice, hydrolyzed soy protein, citrus aurantium dulcis (orange) juice, linalool, citral, red 4, blue 1
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIEHLS SINCE 1851 FACIAL FUEL ENERGIZING MOISTURE TREATMENT FOR MEN BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-583 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITIC ACID (UNII: 2V16EO95H1) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CORN OIL (UNII: 8470G57WFM) CAFFEINE (UNII: 3G6A5W338E) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) MENTHOL (UNII: L7T10EIP3A) LIMONENE, (+)- (UNII: GFD7C86Q1W) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) SODIUM HYDROXIDE (UNII: 55X04QC32I) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) SPANISH CHESTNUT (UNII: 2MT5XMR2YW) LEMON JUICE (UNII: AGN709ANTJ) ORANGE JUICE (UNII: 5A9KE2L9L3) LINALOOL, (+/-)- (UNII: D81QY6I88E) CITRAL (UNII: T7EU0O9VPP) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-583-01 200 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2013 2 NDC:49967-583-02 125 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2013 3 NDC:49967-583-03 75 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2013 4 NDC:49967-583-04 3 mL in 1 PACKET; Type 0: Not a Combination Product 08/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA Products Inc 185931458 manufacture(49967-583)