Hydraphel Day SPF15

Manufacturer: Erno Laszlo, Inc. | Mana Products
Effective date: 2013-04-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:16

Label at a glance#

ProductHydraphel Day SPF15

Active ingredientAvobenzone, Octinoxate

Label structure11 sections

Indications and 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

Dosage and administration

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, ...

Storage and handling

protect this product from excessive heat and direct sun

Contacts and useful links#

PhoneLabel contact866-452-7956

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%, Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ERNO
LASZLO

NEW YORK

HYDRAPHEL

DAY CREAM SPF 15

50mL e 1.7 fl.oz.

Principal Display Panel - 50 mL Jar Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57913-2869-9	2020-01-31	C162847	48780-1	9d75b9d0-1015-f424-e053-dadaa90a57ce	Hydraphel Day SPF15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57913-2869-9	Hydraphel Day SPF15	1 in 1 CARTON	CREAM	1		1
57913-2869-9	Hydraphel Day SPF15	50 mL in 1 JAR	CREAM	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57913-2869	HYDRAPHEL DAY SPF15 (AVOBENZONE AND OCTINOXATE) CREAM [ERNO LASZLO, INC.]	1	Legacy NDC, 2 package rows	20130426_1822b8a0-5bd1-406c-8de0-9f20830e2ae6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
.Alpha.-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
Alkyl (C12-15) Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	1
Allantoin	INACTIVE INGREDIENT	344S277G0Z	1
Caprylyl Glycol	INACTIVE INGREDIENT	00YIU5438U	1
Cetostearyl Alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
Hexyl Laurate	INACTIVE INGREDIENT	4CG9F9W01Q	1
Hexylene Glycol	INACTIVE INGREDIENT	KEH0A3F75J	1
Hyaluronate Sodium	INACTIVE INGREDIENT	YSE9PPT4TH	1
Hydnocarpus Kurzii Seed Oil	INACTIVE INGREDIENT	N757YEZ18Q	1
Hydrogenated Cottonseed Oil	INACTIVE INGREDIENT	Z82Y2C65EA	1
Magnesium Ascorbyl Phosphate	INACTIVE INGREDIENT	0R822556M5	1
PEG-40 Castor Oil	INACTIVE INGREDIENT	4ERD2076EF	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
Polyglyceryl-4 Isostearate	INACTIVE INGREDIENT	820DPX33S7	1
Sodium Dehydroacetate	INACTIVE INGREDIENT	8W46YN971G	1
Soybean Oil	INACTIVE INGREDIENT	241ATL177A	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
Vitamin A Palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

Hydraphel Day SPF15
Avobenzone and Octinoxate
Avobenzone
Octinoxate
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57913-2869	57913-2869-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Avobenzone	G63QQF2NOX	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Water	059QF0KO0R	IACT
Dimethicone	92RU3N3Y1O	IACT
Cetostearyl Alcohol	2DMT128M1S	IACT
Alkyl (C12-15) Benzoate	A9EJ3J61HQ	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
Soybean Oil	241ATL177A	IACT
Hydrogenated Cottonseed Oil	Z82Y2C65EA	IACT
Hydnocarpus Kurzii Seed Oil	N757YEZ18Q	IACT
Polyglyceryl-4 Isostearate	820DPX33S7	IACT
Hexyl Laurate	4CG9F9W01Q	IACT
.Alpha.-Tocopherol Acetate	9E8X80D2L0	IACT
Vitamin A Palmitate	1D1K0N0VVC	IACT
PEG-40 Castor Oil	4ERD2076EF	IACT
Magnesium Ascorbyl Phosphate	0R822556M5	IACT
Hyaluronate Sodium	YSE9PPT4TH	IACT
Edetate Disodium	7FLD91C86K	IACT
Allantoin	344S277G0Z	IACT
Trolamine	9O3K93S3TK	IACT
Sodium Dehydroacetate	8W46YN971G	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Caprylyl Glycol	00YIU5438U	IACT
Hexylene Glycol	KEH0A3F75J	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 163 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Hydrogenated Cottonseed Oil	HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Soybean Oil	SOYBEAN OIL	241ATL177A	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PEG-40 Castor Oil	PEG-40 CASTOR OIL	4ERD2076EF	TABLET / ORAL		9 mg	Exact identifier — unii candidate
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
.Alpha.-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Soybean Oil	SOYBEAN OIL	241ATL177A	INJECTION, EMULSION / INTRAVENOUS		107100 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Hydrogenated Cottonseed Oil	HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	TABLET, DELAYED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Cetostearyl Alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Soybean Oil	SOYBEAN OIL	241ATL177A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	POWDER / TOPICAL	0.02 mg/mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Soybean Oil	SOYBEAN OIL	241ATL177A	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		223 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
Cetostearyl Alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
.Alpha.-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrogenated Cottonseed Oil	HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	TABLET, EXTENDED RELEASE / ORAL		2600 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Hydrogenated Cottonseed Oil	HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	TABLET / SUBLINGUAL	2 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0ecc295b-a0c9-4bef-946d-8e675d3c2e91			1822b8a0-5bd1-406c-8de0-9f20830e2ae6	2013-04-08	Warnings	Exact identifier spl id: 0ecc295b-a0c9-4bef-946d-8e675d3c2e91 spl set id: 1822b8a0-5bd1-406c-8de0-9f20830e2ae6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.