ELIZABETH ARDEN EIGHT HOUR HYDRAPLAY SPF 40- octisalate, homosalate, avobenzone, octocrylene cream

Elizabeth Arden Eight Hour Hydraplay SPF 40 by

Drug Labeling and Warnings

Elizabeth Arden Eight Hour Hydraplay SPF 40 by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corp, Revlon, Inc., iLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0 %

Homosalate 7.0 %

Octisalate 5.0 %

Octocrylene 9.0 %

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

Purpose

Sunscreen

Warnings

• Stop use and ask doctor if rash occurs

Warnings

Do not use on damaged or broken skin

Warnings

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

Warnings

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

Warnings

For external use only.

Inactive Ingredients

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

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

• 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

INGREDIENTS AND APPEARANCE

ELIZABETH ARDEN EIGHT HOUR HYDRAPLAY SPF 40 
octisalate, homosalate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-788
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.5 g  in 50 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FRUCTOSE (UNII: 6YSS42VSEV)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SODIUM PHYTATE (UNII: 88496G1ERL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
PONGAMIA GLABRA SEED OIL (UNII: 62160PU6FJ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
BETAINE (UNII: 3SCV180C9W)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
UNDECANE (UNII: JV0QT00NUE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CITRIC ACID (UNII: 2968PHW8QP)
TOCOPHEROL (UNII: R0ZB2556P8)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
INULIN (UNII: JOS53KRJ01)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLUCOSE (UNII: 5SL0G7R0OK)
SOYBEAN OIL (UNII: 241ATL177A)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
POLYGLYCERYL-4 LAURATE (UNII: 82V7NG3DYT)
SILICA (UNII: ETJ7Z6XBU4)
CELLULOSE GUM (UNII: K679OBS311)
ETHYL FERULATE (UNII: 5B8915UELW)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
RICE GERM (UNII: 7N2B70SFEZ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYGLYCERYL-6 LAURATE (UNII: Q48X4BL3TV)
TRIDECANE (UNII: A3LZF0L939)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-788-50	1 in 1 BOX	03/04/2025
1	NDC: 10967-788-17	50 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/04/2025

Labeler - Revlon Consumer Products Corp (788820165)

Registrant - Revlon, Inc. (188442578)

Establishment
Name	Address	ID/FEI	Business Operations
iLabs		694185577	manufacture(10967-788)