HYDRAPHEL DAY SPF15- avobenzone and octinoxate cream 
Erno Laszlo, Inc.

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.

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Hydraphel Day SPF15

Drug Facts

Active Ingredients

Avobenzone 2%, Octinoxate 7.5%

Purpose

Sunscreen

Uses

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

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?

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 Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2869
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 4/2013
Document Id: 0ecc295b-a0c9-4bef-946d-8e675d3c2e91
Set id: 1822b8a0-5bd1-406c-8de0-9f20830e2ae6
Version: 1
Effective Time: 20130408
 
Erno Laszlo, Inc.