Label: HYDRAPHEL DAY SPF15- avobenzone and octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57913-2869-9 - Packager: Erno Laszlo, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 8, 2013
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
Apply liberally 15 minutes before sun exposure
- reapply: after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
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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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
Water, Dimethicone, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Hydrogenated Polyisobutene, Glyceryl Stearate, PEG-100 Stearate, Glycerin Soja (Soybean) Oil, Hydrogenated Cottenseed Oil, Taraktogenos Kurzii Seed Oil, Polyglyceryl-4 Isostearate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Hydrogenated Olive Oil, Tocopheryl Acetate, Retinyl Palmitate, PEG-40 Castor Oil, Magnesium Ascorbyl Phosphate, Sodium Hyaluronate, Disodium EDTA, Allantoin, Carbomer, Triethanolamine, Sodium Dehydroacetate, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol.
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
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INGREDIENTS AND APPEARANCE
HYDRAPHEL DAY SPF15
avobenzone and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2869 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Dimethicone (UNII: 92RU3N3Y1O) Cetostearyl Alcohol (UNII: 2DMT128M1S) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Glyceryl Monostearate (UNII: 230OU9XXE4) Soybean Oil (UNII: 241ATL177A) Hydrogenated Cottonseed Oil (UNII: Z82Y2C65EA) Hydnocarpus Kurzii Seed Oil (UNII: N757YEZ18Q) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Hexyl Laurate (UNII: 4CG9F9W01Q) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Vitamin A Palmitate (UNII: 1D1K0N0VVC) PEG-40 Castor Oil (UNII: 4ERD2076EF) Magnesium Ascorbyl Phosphate (UNII: 0R822556M5) Hyaluronate Sodium (UNII: YSE9PPT4TH) Edetate Disodium (UNII: 7FLD91C86K) Allantoin (UNII: 344S277G0Z) Trolamine (UNII: 9O3K93S3TK) Sodium Dehydroacetate (UNII: 8W46YN971G) Phenoxyethanol (UNII: HIE492ZZ3T) Caprylyl Glycol (UNII: 00YIU5438U) Hexylene Glycol (UNII: KEH0A3F75J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57913-2869-9 1 in 1 CARTON 1 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/10/2013 Labeler - Erno Laszlo, Inc. (098821031) Establishment Name Address ID/FEI Business Operations Mana Products 078870292 MANUFACTURE(57913-2869) , LABEL(57913-2869) , PACK(57913-2869)
