Label: HYDRAPHEL DAY SPF15- avobenzone and octinoxate cream
- NDC Code(s): 57913-2869-9
- Packager: Erno Laszlo, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active Ingredients
Avobenzone 2%, Octinoxate 7.5%Close
For external use only.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away.
Apply liberally 15 minutes before sun exposure
- reapply: after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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
- 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.Close
- Other information
- protect this product from excessive heat and direct sun
- Questions or comments?
Call toll free at 866-452-7956.Close
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DISTRIBUTED IN U.S.A. BY ERNO LASZLO NEW YORK, NY 10001Close
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
DAY CREAM SPF 15
50mL e 1.7 fl.oz.
- INGREDIENTS AND APPEARANCE
HYDRAPHEL DAY SPF15
avobenzone and octinoxate cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57913-2869 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (Avobenzone) Avobenzone 20 mg in 1 mL Octinoxate (Octinoxate) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water Dimethicone Cetostearyl Alcohol Alkyl (C12-15) Benzoate Glyceryl Monostearate Soybean Oil Hydrogenated Cottonseed Oil Hydnocarpus Kurzii Seed Oil Polyglyceryl-4 Isostearate Hexyl Laurate .Alpha.-Tocopherol Acetate Vitamin A Palmitate PEG-40 Castor Oil Magnesium Ascorbyl Phosphate Hyaluronate Sodium Edetate Disodium Allantoin Trolamine Sodium Dehydroacetate Phenoxyethanol Caprylyl Glycol Hexylene Glycol 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)