NDC | 49967-248-01, 49967-248-02, 49967-248-03, 49967-248-04 |
Set ID | 69575d95-8d33-4813-86f9-89cbd3429a61 |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- 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 sunglassess
- children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
water, dimethicone, alcohol denat., styrene/acrylates copolymer, acrylates/dimethicone copolymer, tocopherol, sodium polyacrylate, sodium dodecylbenzenesulfonate, sodium benzoate, phenoxyethanol, PEG-8 laurate, silica, pentylene glycol, mentha piperita (peppermint) extract, propylene glycol, leontopodium alpinum flower/leaf extract, caprylyl glycol, acrylates/C-10-30 alkyl acrylate crosspolymer, sorbitol, moringa oleifera seed extract, disodium EDTA, rosa gallica flower extract, disodium phosphate, citric acid, potassium sorbate, glycerin, fragrance
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LANCOME UV EXPERT AQUAGEL DEFENSE 50 BROAD SPECTRUM SPF 50 WITH ANTIOXIDANT VITAMIN E
avobenzone, homosalate, octisalate, octocrylene and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-248 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 107 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 32 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 39 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ALCOHOL (UNII: 3K9958V90M) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-8 LAURATE (UNII: 762O8IWA10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PENTYLENE GLYCOL (UNII: 50C1307PZG) MENTHA PIPERITA (UNII: 79M2M2UDA9) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITOL (UNII: 506T60A25R) MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0) EDETATE DISODIUM (UNII: 7FLD91C86K) ROSA GALLICA FLOWER (UNII: X8W61WUV70) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-248-01 1 in 1 CARTON 01/15/2018 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-248-02 1 in 1 CARTON 01/15/2018 2 10 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49967-248-03 1 in 1 CARTON 01/15/2018 3 5 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:49967-248-04 1 in 1 CARTON 01/15/2018 4 1 mL in 1 TUBE; 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 01/15/2018 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations SICOS ET CIE 276993581 manufacture(49967-248)