FDA.reportPublic FDA data

Elizabeth Arden Eight Hour Hydraplay SPF 40

Manufacturer
Revlon Consumer Products Corp | Revlon, Inc. | iLabs
Effective date
2025-06-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:12

Label at a glance#

ProductElizabeth Arden Eight Hour Hydraplay SPF 40
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure12 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

Directions For Sunscreen Use: shake well and apply liberally 15 minutes before sun exposure and makeup application reapply: at least every 2 hours even over makeup use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending timine in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0 %

Homosalate 7.0 %

Octisalate 5.0 %

Octocrylene 9.0 %

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

OTC - STOP USE SECTION

  • Stop use and ask doctor if rash occurs

Warnings

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

Warnings

OTC - WHEN USING SECTION

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

Warnings

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.

Warnings

WARNINGS SECTION

For external use only.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Pongamia Glabra Seed Oil, Undecane, Betaine, Silica, 1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Caprylyl Glycol, Cellulose, Cellulose Gum, Citric Acid, Dunaliella Salina Extract, Ethyl Ferulate, Fructose, Glucose, Glycine Soja (Soybean) Oil, Glycine Soja (Soybean) Seed Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Inulin, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Polyglyceryl-3 Diisostearate, Polyglyceryl-4 Laurate, Polyglyceryl-6 Laurate, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Dilauramidoglutamide Lysine, Sodium Phytate, Sorbitan Isostearate, Tocopherol, Tridecane, Xanthan Gum, Potassium Sorbate, Sodium Benzoate.

Directions

INSTRUCTIONS FOR USE SECTION

Directions For Sunscreen Use:

  • shake well and apply liberally 15 minutes before sun exposure and makeup application
  • reapply: at least every 2 hours even over makeup
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending timine in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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.

Directions For Sunscreen Use

DOSAGE & ADMINISTRATION SECTION

  • Shake well and apply liberally 15 minutes before sun exposure and makeup application
  • Reapply: at least every 2 hours even over makeup
  • use a water resistant sunscreen if swimming or sweating

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outermost LevelOutermost Level

Innermost LevelInnermost Level

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-788-17Elizabeth Arden Eight Hour Hydraplay SPF 4050 g in 1 BOTTLECREAM502
10967-788-50Elizabeth Arden Eight Hour Hydraplay SPF 401 in 1 BOXCREAM12

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-78810967-788-17, 10967-788-50

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTISALATE4X49Y0596WACTIB
FRUCTOSE6YSS42VSEVIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
SODIUM PHYTATE88496G1ERLIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
PONGAMIA GLABRA SEED OIL62160PU6FJIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
BETAINE3SCV180C9WIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
UNDECANEJV0QT00NUEIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CITRIC ACID2968PHW8QPIACT
TOCOPHEROLR0ZB2556P8IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
POWDERED CELLULOSESMD1X3XO9MIACT
DUNALIELLA SALINAF4O1DKI9A6IACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
INULINJOS53KRJ01IACT
POLYSORBATE 60CAL22UVI4MIACT
CAPRYLYL GLYCOL00YIU5438UIACT
AVOBENZONEG63QQF2NOXACTIB
GLUCOSE5SL0G7R0OKIACT
SOYBEAN OIL241ATL177AIACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
POLYGLYCERYL-4 LAURATE82V7NG3DYTIACT
SILICAETJ7Z6XBU4IACT
CELLULOSE GUMK679OBS311IACT
ETHYL FERULATE5B8915UELWIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
RICE GERM7N2B70SFEZIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Elizabeth Arden Eight Hour Hydraplay SPF 40OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENERevlon Consumer Products Corp2cc74177-0f62-106e-e063-6394a90a6e282025-06-16WarningsExact identifier
ndc (package): 10967-788-50
ndc (package): 10967-788-17
ndc (product): 10967-788
ndc11 (package): 10967078817
ndc11 (package): 10967078850
spl id: 37b28f93-a43b-abd0-e063-6394a90aa079
spl set id: 2cc74177-0f62-106e-e063-6394a90a6e28

Reported adverse events (FAERS/openFDA)#

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