NDC | 49967-099-01, 49967-099-02, 49967-099-03 |
Set ID | fb9daea3-c249-417c-ad34-3e89f3118559 |
Category | HUMAN OTC DRUG LABEL |
Packager | L’Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredient
- 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:
- 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, squalene, dimethicone, PEG-100 stearate, glyceryl stearate, silica, octyldodecanol, stearic acid, phenoxyethanol, palmitic acid, tocopherol, dicaprylyl carbonate, steareth-100, acrylates/c10-30 alkyl acrylate crosspolymer, ophiopogon japonicus root extract, carbomer, chlorphenesin, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, sodium hydroxide, citrus aurantium dulcis (orange) peel oil, limonene, ectoin, hydrolyzed hyaluronic acid, myristic acid, mentha piperita (peppermint) oil, pseudoalteromonas ferment extract, ethylhexylglycerin, linalool, salicylic acid
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KIEHLS SINCE 1851 ULTRA FACIAL BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-099 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SQUALANE (UNII: GW89575KF9) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-100 STEARATE (UNII: YD01N1999R) OCTYLDODECANOL (UNII: 461N1O614Y) STEARIC ACID (UNII: 4ELV7Z65AP) PHENOXYETHANOL (UNII: HIE492ZZ3T) PALMITIC ACID (UNII: 2V16EO95H1) TOCOPHEROL (UNII: R0ZB2556P8) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) STEARETH-100 (UNII: 4OH5W9UM87) CHLORPHENESIN (UNII: I670DAL4SZ) CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM HYDROXIDE (UNII: 55X04QC32I) SALICYLIC ACID (UNII: O414PZ4LPZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-099-01 50 mL in 1 JAR; Type 0: Not a Combination Product 11/01/2015 2 NDC:49967-099-02 125 mL in 1 JAR; Type 0: Not a Combination Product 11/01/2015 3 NDC:49967-099-03 3 mL in 1 PACKET; Type 0: Not a Combination Product 11/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2015 Labeler - L’Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L’Oreal USA, Inc. 185931458 manufacture(49967-099)