Label: ABSOLUE PREMIUM BX SUNSCREEN BROAD SPECTRUM SPF 15 ABSOLUTE REPLENISHING- avobenzone, octisalate, octocrylene cream
- NDC Code(s): 70581-003-75
- Packager: BPS 60
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 9, 2023
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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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
- 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: Sun Protection Measures.
- 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
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INGREDIENTS AND APPEARANCE
ABSOLUE PREMIUM BX SUNSCREEN BROAD SPECTRUM SPF 15 ABSOLUTE REPLENISHING
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70581-003 Route of Administration TOPICAL, 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) GLYCERIN (UNII: PDC6A3C0OX) 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) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) 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) LAURETH-7 (UNII: Z95S6G8201) HEXYLDECANOL (UNII: 151Z7P1317) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70581-003-75 1 in 1 BOX 04/09/2016 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 Drug M020 04/09/2016 Labeler - BPS 60 (272259304) Establishment Name Address ID/FEI Business Operations BPS 60 272259304 pack(70581-003)
