NDC | 49967-250-02 |
Set ID | 4a38cc31-7a86-4e64-b247-69a442a5d836 |
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.
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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, cyclohexasiloxane, alcohol denat., caprylic/capric triglyceride, PEG-20 methyl glucose sesquistearate, C12-15 alkyl benzoate, tocopheryl acetate, C13-14 isoparaffin, hydroxypropyl tetrahydropyrantriol, hydrolyzed malt extract, padina pavonica extract, hydrolyzed soy protein, stearic acid, adenosine, triethanolamine, polyacrylamide, calcium pantothenate, dimethyl isosorbide, limonene, xanthan gum, linalool, dioscorea villosa (wild yam) root extract, iron oxides, caprylyl glycol, capryloyl salicylic acid, paraffin, disodium EDTA, butylene glycol, cetyl alcohol, octyldodecanol, citronellol, laureth-7, hexyldecanol, fragrance
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LANCOME PARIS ABSOLUE PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE REPLENISHING
avobenzone, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-250 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1) PADINA PAVONICA (UNII: 177U06NHZI) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) STEARIC ACID (UNII: 4ELV7Z65AP) ADENOSINE (UNII: K72T3FS567) TROLAMINE (UNII: 9O3K93S3TK) POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) LIMONENE, (+)- (UNII: GFD7C86Q1W) XANTHAN GUM (UNII: TTV12P4NEE) LINALOOL, (+/-)- (UNII: D81QY6I88E) DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) FERRIC OXIDE RED (UNII: 1K09F3G675) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4) PARAFFIN (UNII: I9O0E3H2ZE) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETYL ALCOHOL (UNII: 936JST6JCN) OCTYLDODECANOL (UNII: 461N1O614Y) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LAURETH-7 (UNII: Z95S6G8201) HEXYLDECANOL (UNII: 151Z7P1317) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-250-02 1 in 1 CARTON 02/01/2010 1 75 mL in 1 BOTTLE; 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 02/01/2010 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations SICOS ET CIE 276993581 manufacture(49967-250) Establishment Name Address ID/FEI Business Operations BPS60 272259304 pack(49967-250)