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

Almay Anti Aging Lip Care SPF 20 by

Drug Labeling and Warnings

Almay Anti Aging Lip Care SPF 20 by is a Otc medication manufactured, distributed, or labeled by Almay, Inc., REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ALMAY ANTI AGING LIP CARE SPF 20 
octinoxate, octisalate, homosalate, oxybenzone, avobenzone lipstick

Product 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)