Label: LANCOME PARIS ABSOLUE BX MAKEUP BROAD SPECTRUM SPF 18 SUNSCREEN ABSOLUTE REPLENISHING RADIANT MAKEUP NORMAL TO DRY SKIN- octinoxate liquid
- NDC Code(s): 49967-439-01, 49967-439-02
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 30, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Caution
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
For sunscreen use:
● shake well
● 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
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Inactive ingredients
water, isohexadecane, dipentaerythrityl hexacaprylate/hexacaprate, isodecyl neopentanoate, glycerin, alcohol denat., PEG-30 dipolyhydroxystearate, methyl methacrylate crosspolymer, dicaprylyl carbonate, propanediol, paraffin, glycyrrhiza glabra (licorice) root extract, padina pavonica extract, aluminum hydroxide, adenosine, magnesium sulfate, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, propylene glycol, hydroxypropyl tetrahydropyrantriol, caprylyl glycol, dioscorea villosa (wild yam) root extract, disteardimonium hectorite, hexyldecanol, tocopheryl acetate, phenoxyethanol, linalool, limonene, citronellol, fragrance; may conain: titanium dioxide, iron oxides
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LANCOME PARIS ABSOLUE BX MAKEUP BROAD SPECTRUM SPF 18 SUNSCREEN ABSOLUTE REPLENISHING RADIANT MAKEUP NORMAL TO DRY SKIN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-439 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PROPANEDIOL (UNII: 5965N8W85T) PARAFFIN (UNII: I9O0E3H2ZE) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) PADINA PAVONICA (UNII: 177U06NHZI) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ADENOSINE (UNII: K72T3FS567) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) EDETATE DISODIUM (UNII: 7FLD91C86K) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) HEXYLDECANOL (UNII: 151Z7P1317) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+)- (UNII: GFD7C86Q1W) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-439-01 1 in 1 CARTON 01/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-439-02 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2017 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp. 783200723 manufacture(49967-439) , pack(49967-439) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 analysis(49967-439)