NDC | 49967-631-01 |
Set ID | 3ff5ad0d-7c23-42cb-8017-e09c927755b9 |
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:
● apply liberally 15 minutes before sun exposure
● reapply:
● after 80 minutes of swimming or sweating
● immediately after towel drying
● at least every 2 hours
● 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, dimethicone, isododecane, styrene/acrylates copolymer, propanediol, glycerin, silica, isononyl isononanoate, inulin lauryl carbamate, nylon-12, caprylyl methicone, synthetic wax, poly C10-30 alkyl acrylate, phenoxyethanol, lycium barbarum fruit extract, sucrose tristearate, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, PEG-8 laurate, stearyl alcohol, polymethyl methacrylate, p-anisic acid, chlorphenesin, dimethiconol, xanthan gum, disodium EDTA, tocopherol, triethanolamine, hydrolyzed triticum monococcum seed extract
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR FOR FACE BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-631 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 150 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 OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) NYLON-12 (UNII: 446U8J075B) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A) PHENOXYETHANOL (UNII: HIE492ZZ3T) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) SUCROSE TRISTEARATE (UNII: 71I93STU5M) PEG-8 LAURATE (UNII: 762O8IWA10) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) P-ANISIC ACID (UNII: 4SB6Y7DMM3) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) TOCOPHEROL (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-631-01 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2013 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising Inc. 076693183 manufacture(49967-631)