Label: ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR- lip protectant lipstick
- NDC Code(s): 10967-676-64
- Packager: REVLON CONSUMER PRODUCTS CORP
- 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 1, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- 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 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
- Other Information
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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?
- Skin protectant Directions
- Keep out of reach of children
- Uses
- Directions and Usage
- Packaging Label
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INGREDIENTS AND APPEARANCE
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR
lip protectant lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-676 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-676-64 3.7 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 02/01/2023 Labeler - REVLON CONSUMER PRODUCTS CORP (788820165) Establishment Name Address ID/FEI Business Operations REVLON, INC 809725570 manufacture(10967-676)
