ALMAY ANTI AGING LIP CARE SPF 20- octinoxate, octisalate, homosalate, oxybenzone, avobenzone lipstick 
Almay, Inc.

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.

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Almay Anti Aging Lip Care SPF 20

Active Ingredients:

Octinoxate - 7.5%

Octisalate 5%

Homosalate 5.0%

Oxybenzone 5.0%

Avobenzone 3%

Purpose


Sunscreen

Uses:

•Helps prevent sunburn
•If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

•For external use only
•Do notuse on damaged or broken skin
•When using this product: Keep out of eyes. Rinse with water to remove.
•Stop use and ask a doctor if a rash occurs
•Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away

Directions

•Apply liberally 15 minutes before sun exposure
•Use a water resistant sunscreen if swimming or sweating
•Reapply at least every 2 hours
•Children under 6 months: Ask a doctor.

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

Principal Display Panel

Almay

Almay Anti Aging Lip Care SPF 20

0.24 Oz. / 6.8 g

Label

ALMAY ANTI AGING LIP CARE SPF 20 
octinoxate, octisalate, homosalate, oxybenzone, avobenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0709
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0311-0709-016.8 mL in 1 CONTAINER; Type 0: Not a Combination Product04/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/20/2016
Labeler - Almay, Inc. (064988652)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(0311-0709)

Revised: 10/2019
Document Id: 9585b71f-eb7a-2563-e053-2995a90ad376
Set id: dfb858ae-5750-4a24-abc5-674ff27bdeca
Version: 3
Effective Time: 20191022
 
Almay, Inc.