Your browser does not support JavaScript! HYDRAPHEL DAY SPF15 (AVOBENZONE AND OCTINOXATE) CREAM [ERNO LASZLO, INC.]
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HYDRAPHEL DAY SPF15 (avobenzone and octinoxate) cream
[Erno Laszlo, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Drug Facts

Active Ingredients

Avobenzone 2%, Octinoxate 7.5%

Purpose

Sunscreen

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

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away.

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
  • 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.

Other information

  • protect this product from excessive heat and direct sun

Questions or comments?

Call toll free at 866-452-7956.

DISTRIBUTED IN U.S.A. BY ERNO LASZLO NEW YORK, NY 10001

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

ERNO
LASZLO

NEW YORK

HYDRAPHEL

DAY CREAM SPF 15

50mL e 1.7 fl.oz.

Principal Display Panel - 50 mL Jar Carton
HYDRAPHEL DAY SPF15 
avobenzone and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57913-2869
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone20 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57913-2869-91 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/10/2013
Labeler - Erno Laszlo, Inc. (098821031)
Establishment
NameAddressID/FEIBusiness Operations
Mana Products078870292MANUFACTURE(57913-2869), LABEL(57913-2869), PACK(57913-2869)

Revised: 4/2013
 
Erno Laszlo, Inc.

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