NDC | 49967-502-01, 49967-502-02, 49967-502-03 |
Set ID | 02c51b56-e39a-4b3b-88c6-b7dc9c165f7e |
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 generously and evenly 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
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Inactive ingredients
water, glycerin, dimethicone, PTFE, octyldodecanol, alcohol denat., isopropyl isostearate, methylsilanol/silicate crosspolymer, arachidyl alcohol, tocopheryl acetate, medicago sativa (alfalfa) extract, hydrolyzed rice protein, sodium chloride, sodium hyaluronate, phenoxyethanol, acetyl trifluoromethylphenyl valylglycine, adenosine, PEG-100 stearate, behenyl alcohol, polysorbate 80, silica, cellulose acetate butyrate, polyphosphorylcholine glycol acrylate, polyvinyl alcohol, dimethicone/vinyl dimethicone crosspolymer, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethiconol, limonene, ammonium polyacryloyldimethyl taurate, manganese gluconate, linalool, benzyl alcohol, isohexadecane, capryloyl salicylic acid, alpha-isomethyl ionone, acrylamide/sodium acryloyldimethyltaurate copolymer, carbomer, geraniol, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, cetearyl alcohol, methylparaen, cetearyl glucoside, butylphenyl methylpropional, methylisothiazolinone, citronellol, butylene glycol, coumarin, fragrance
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LANCOME PARIS HIGH RESOLUTION REFILL 3X TRIPLE ACTION RENEWAL ANTI WRINKLE BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, octisalate and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-502 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 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 30 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O) OCTYLDODECANOL (UNII: 461N1O614Y) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PHENOXYETHANOL (UNII: HIE492ZZ3T) ACETYL TRIFLUOROMETHYLPHENYL VALYLGLYCINE, DL- (UNII: 95SP8380V9) ADENOSINE (UNII: K72T3FS567) PEG-100 STEARATE (UNII: YD01N1999R) DOCOSANOL (UNII: 9G1OE216XY) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CELLABURATE (MW 12000, 32% BUTYRYL, 18% ACETYL) (UNII: I94M7L124G) POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) LIMONENE, (+)- (UNII: GFD7C86Q1W) MANGANESE (UNII: 42Z2K6ZL8P) GLUCONATE ION (UNII: W552L9Y4VZ) LINALOOL, (+/-)- (UNII: D81QY6I88E) BENZYL ALCOHOL (UNII: LKG8494WBH) ISOHEXADECANE (UNII: 918X1OUF1E) CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) GERANIOL (UNII: L837108USY) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) EDETATE DISODIUM (UNII: 7FLD91C86K) CETYL ALCOHOL (UNII: 936JST6JCN) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) METHYLPARABEN (UNII: A2I8C7HI9T) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) COUMARIN (UNII: A4VZ22K1WT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-502-01 1 in 1 CARTON 08/01/2013 1 75 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:49967-502-02 1 in 1 CARTON 08/01/2013 2 50 g in 1 JAR; Type 0: Not a Combination Product 3 NDC:49967-502-03 1 in 1 CARTON 08/01/2013 3 15 g in 1 JAR; Type 0: Not a Combination Product 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 SICOS ET CIE 276993581 manufacture(49967-502) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-502)