ACTIVE INGREDIENTS

ACTIVE INGREDIENT PURPOSE

PETROLATUM 31.0% SKIN PROTECTANT

AVOBENZONE 2.0% SUNSCREEN

OCTINOXATE 7.5% SUNSCREEN

OXYBENZONE 3.0% SUNSCREEN

USES

helps prevent sunburn
Temporarily protects and helps relieve
chapping
peeling or flaking due to minor sunburn
windburn
cracked lips

Warnings

Skin Cancer/Skin Aging Alert: spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only
Do not use on damaged or broken skin
Stop use and ask a doctor if rash occurs or if condition lasts more than 7 days.
Keep out of reach of children.If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally as often as necessary

For Sunscreen Use:

Apply liberally 15 minutes before sun exposure
reapply:
atleast every 2 hours
children under 6 months: Ask a doctor.

Other Information

Other information

Protect this product from excessive heat and direct sun

Inactive ingedients

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Polyethylene, Diisostearyl Malate, Ozokerite, Lanolin, Octyldodecyl Neopentanoate, Synthetic Fluorphlogopite, Hydrogenated Polyisobutene, Cetyl PEG/PPG-10/1 Dimethicone, Mica, Polyglyceryl-4 Isostearate, Hexyl Laurate, Synthetic Wax, BHT, Butyrospermum Parkii (Shea) Butter, Cera Alba/Beeswax/Cire D’abeille, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Parfum (Fragrance), Citral, Citronellol, Geraniol, Limonene, Linalool, Benzoic Acid. MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Iron Oxides (CI 77491), Iron Oxides (CI 77499), Red 33 Lake (CI 17200), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).]

Questions or Comments?

Call toll free 1-800-326-7337
Monday to Friday, 10:00AM to 7:00PM EST

Skin protectant Directions

Apply liberally as often as necessary

Keep out of reach of children

Keep out of reach of children.

If product is swallowed, get medical help or contact poison control center right away.

Uses

Helps prevent sunburn
Temporarily protects and helps relieve
Chapping
Peeling or flaking due to minor sunburn
Windburn
Cracked lips

Directions and Usage

Apply liberally as often as necessary
For sunscreen use: apply liberally 15 minutes before sun exposure
Reapply: atleast every 2 hours
Children under 6 months: ask a doctor

Packaging Label

Carton Packaging Onsert

ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR
lip protectant lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10967-676
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1.147 g in 3.7 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.2775 g in 3.7 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.111 g in 3.7 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.074 g in 3.7 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
CERESIN (UNII: Q1LS2UJO3A)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
FRAGRANCE 13576 (UNII: 5EM498GW35)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
LANOLIN (UNII: 7EV65EAW6H)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10967-676-64	3.7 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	02/01/2023

Labeler - REVLON CONSUMER PRODUCTS CORP (788820165)

Name	Address	ID/FEI	Business Operations
Establishment
REVLON, INC		809725570	manufacture(10967-676)

ELIZABETH ARDEN EIGHT HOUR CREAM LIP PROTECTANT STICK SUNSCREEN SPF 15- CLEAR