Label: ALMAY ANTI AGING LIP CARE SPF 20- octinoxate, octisalate, homosalate, oxybenzone, avobenzone lipstick
- NDC Code(s): 0311-0709-01
- Packager: Almay, Inc.
- 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 October 22, 2019
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- Active Ingredients:
- Purpose
- Uses:
- Warnings:
- Directions
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Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
•Limit time in the sun, especially from 10 am - 2 pm
•Wear long-sleeved shirts, pants, hats and sunglasses. -
Inactive Ingredients
Polybutene, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Ozokerite, Octyldodecyl Neopentanoate, Petrolatum, Polyethylene, C10-30 Cholesterol/Lanosterol Esters, Synthetic Fluorphlogopite, Silica, Paraffin, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Dimethicone, Synthetic Wax, Nylon-12, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Cetearyl Ethylhexanoate, Mica, Flavor, Tocopheryl Acetate, Diisopropyl Dimer Dilinoleate, Menthol, Titanium Dioxide (CI 77891), Benzoic Acid, BHT, Phospholipids, Sorbitan Isostearate, Sodium Saccharin, Silica Dimethyl Silylate, Portulaca Pilosa Extract, Aqua/Water/Eau, Caprylyl Glycol, Butylene Glycol, Phenoxyethanol, Sucrose Cocoate, Hyaluronic Acid, Sodium Chondroitin Sulfate, Atelocollagen, Tocopherol, Sodium Hyaluronate, Hexylene Glycol, Soluble Collagen, Tripeptide-29, Palmitoyl Tripeptide-38, Methyl Acetylglycyrrhetinoyl Hydroxyprolinate
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INGREDIENTS AND APPEARANCE
ALMAY ANTI AGING LIP CARE SPF 20
octinoxate, octisalate, homosalate, oxybenzone, avobenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0311-0709 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PETROLATUM (UNII: 4T6H12BN9U) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) PARAFFIN (UNII: I9O0E3H2ZE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SHEA BUTTER (UNII: K49155WL9Y) DIMETHICONE (UNII: 92RU3N3Y1O) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) NYLON-12 (UNII: 446U8J075B) COCONUT (UNII: 3RT3536DHY) ETHYLHEXYL PALMITATE (UNII: 2865993309) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) MICA (UNII: V8A1AW0880) MENTHOL (UNII: L7T10EIP3A) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BENZOIC ACID (UNII: 8SKN0B0MIM) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENOXYETHANOL (UNII: HIE492ZZ3T) SUCROSE COCOATE (UNII: 3H18P0UK73) HYALURONIC ACID (UNII: S270N0TRQY) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) TOCOPHEROL (UNII: R0ZB2556P8) CERESIN (UNII: Q1LS2UJO3A) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) HEXYLENE GLYCOL (UNII: KEH0A3F75J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0311-0709-01 6.8 mL in 1 CONTAINER; Type 0: Not a Combination Product 04/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/20/2016 Labeler - Almay, Inc. (064988652) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(0311-0709)
