Label: EA EIGHT HR LIP SHEER TINTS- oxybenzone, padimate o, petrolatum lipstick
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- NDC Code(s): 10967-674-61
- Packager: REVLON
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 9, 2022
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- ACTIVE INGREDIENTS
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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
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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
- CARTON ART
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INGREDIENTS AND APPEARANCE
EA EIGHT HR LIP SHEER TINTS
oxybenzone, padimate o, petrolatum lipstickProduct 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) GERANIOL (UNII: L837108USY) 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) 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 final part352 04/17/2019 Labeler - REVLON (788820165) Registrant - REVLON (788820165) Establishment Name Address ID/FEI Business Operations Revlon 809725570 manufacture(10967-674)
