HYDRAPHEL DAY SPF15- avobenzone and octinoxate cream

Hydraphel Day SPF15 by

Drug Labeling and Warnings

Hydraphel Day SPF15 by is a Otc medication manufactured, distributed, or labeled by Erno Laszlo, Inc., Mana Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

HYDRAPHEL DAY SPF15 
avobenzone and octinoxate cream

Product 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)