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NDC 00311-0709-01 Almay Anti Aging Lip Care SPF 20 3; 5; 7.5; 5; 5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

Almay Anti Aging Lip Care SPF 20 3; 5; 7.5; 5; 5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

Almay Anti Aging Lip Care SPF 20 is a TOPICAL LIPSTICK in the HUMAN OTC DRUG category. It is labeled and distributed by Almay, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE.

Product Information

NDC	00311-0709
Product ID	0311-0709_9585b71f-eb7a-2563-e053-2995a90ad376
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Almay Anti Aging Lip Care SPF 20
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate, Octisalate, Homosalate, Oxybenzone, Avobenzone
Product Type	HUMAN OTC DRUG
Dosage Form	LIPSTICK
Route	TOPICAL
Active Ingredient Strength	3; 5; 7.5; 5; 5
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Labeler Name	Almay, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00311-0709-01 (00311070901)

Pricing Information	N/A
NDC Package Code	0311-0709-01
Billing NDC	00311070901
Package	6.8 mL in 1 CONTAINER (0311-0709-01)
Marketing Start Date	2016-04-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dfb858ae-5750-4a24-abc5-674ff27bdeca Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0311-0709-01	6.8 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/20/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/20/2016

Labeler - Almay, Inc. (064988652)

Name	Address	ID/FEI	Business Operations
Establishment
REVLON, INC.		809725570	manufacture(0311-0709)

Revised: 10/2019

Document Id: 9585b71f-eb7a-2563-e053-2995a90ad376

Set id: dfb858ae-5750-4a24-abc5-674ff27bdeca

Version: 3

Effective Time: 20191022