EA EIGHT HR LIP SHEER TINTS- oxybenzone, padimate o, petrolatum lipstick

EA EIGHT HR LIP SHEER TINTS by

Drug Labeling and Warnings

EA EIGHT HR LIP SHEER TINTS by is a Otc medication manufactured, distributed, or labeled by REVLON, Revlon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

OCTINOXATE 7.5%...................Sunscreen
OXYBENZONE 3.0%.................Sunscreen
AVOBENZONE 2.0%.................Sunscreen

INACTIVE INGREDIENTS

POLYBUTENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, DIISOSTEARYL MALATE, POLYETHYLENE, OZOKERITE, LANOLIN, OCTYLDODECYL NEOPENTANOATE, HYDROGENATED POLYISOBUTENE, SYNTHETIC FLUORPHLOGOPITE, CETYL
PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, SYNTHETIC WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, CERA ALBA (BEESWAX (CIRE D’ABEILLE)), COCOS NUCIFERA (COCONUT) OIL, TOCOPHERYL ACETATE, PARFUM (FRAGRANCE), BENZOIC ACID, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, BHT,

MAY CONTAIN: IRON OXIDES (CI 77491, CI 77499), MICA, RED 33 LAKE (CI 17200), RED 6 LAKE (CI 15850), RED 7 LAKE (CI 15850), TITANIUM DIOXIDE (CI 77891), YELLOW 5 LAKE (CI 19140).

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

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

DIRECTIONS

Directions
■ Apply liberally as often as necessary

For Sunscreen Use:
■ Apply liberally 15 minutes before sun exposure
■ reapply:
■ at least every 2 hours
■ use a water resistant sunscreen if swimming or sweating
■ children under 6 months: Ask a doctor.

DOSAGE & ADMINISTRATION

As needed

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Sunscreen

Skin Protectant

CARTON ART

INGREDIENTS AND APPEARANCE

EA EIGHT HR LIP SHEER TINTS 
oxybenzone, padimate o, petrolatum lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-674
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	8 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30.2 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ACETATE (UNII: 4Q43814HXS)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CETYL LACTATE (UNII: A7EVH2RK4O)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SOYBEAN OIL (UNII: 241ATL177A)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
LANOLIN OIL (UNII: OVV5IIJ58F)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MYRISTYL LACTATE (UNII: 1D822OC34X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERYL ROSINATE (UNII: SD112V492J)
TOCOPHEROL (UNII: R0ZB2556P8)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CORN OIL (UNII: 8470G57WFM)
CASTOR OIL (UNII: D5340Y2I9G)
WHITE WAX (UNII: 7G1J5DA97F)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CANDELILLA WAX (UNII: WL0328HX19)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-674-61	3.7 g in 1 CARTRIDGE; Type 0: Not a Combination Product	04/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/17/2019

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon		809725570	manufacture(10967-674)