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NDC 00311-0710-01 ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 5.5; 2.4 mg/mL; mg/mL Details

ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 5.5; 2.4 mg/mL; mg/mL

ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Almay, Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	00311-0710
Product ID	0311-0710_9586054e-7c80-da13-e053-2a95a90a96e5
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 SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	5.5; 2.4
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Almay, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00311-0710-01 (00311071001)

Pricing Information	N/A
NDC Package Code	0311-0710-01
Billing NDC	00311071001
Package	30 mL in 1 TUBE (0311-0710-01)
Marketing Start Date	2016-04-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4418b335-80e8-1395-e054-00144ff88e88 Details

Active Ingredients:

Titanium Dioxide: 5.5%

Zinc Oxide 2.4%

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

CYCLOPENTASILOXANE, AQUA ((WATER) EAU), DIMETHICONE, PHENYL TRIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SILICA, NYLON-12, TRIBEHENIN, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, TOCOPHERYL ACETATE, NIACINAMIDE, PISUM SATIVUM (PEA) EXTRACT, GLYCINE SOJA (SOYBEAN) OIL, HYDROLYZED RICE PROTEIN, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT, LAMINARIA JAPONICA EXTRACT, NEREOCYSTIS LUETKEANA EXTRACT, MACROCYSTIS PYRIFERA (KELP) EXTRACT, SACCHAROMYCES/MAGNESIUM FERMENT, SACCHAROMYCES/POTASSIUM FERMENT, PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER, SODIUM HYALURONATE, OLIGOPEPTIDE-24, GLYCERIN, PALMITOYL TRIPEPTIDE-5, MELANIN, POLYESTER-1, LAURETH-7, MAGNESIUM SULFATE, POLYGLYCERYL-3 DIISOSTEARATE, METHICONE, TRIETHOXYCAPRYLYLSILANE, POLYSILICONE-11, DISTEARDIMONIUM HECTORITE, ETHYLENE BRASSYLATE, SILICA DIMETHYL SILYLATE, TRIETHYL CITRATE, TETRASODIUM EDTA, DIPROPYLENE GLYCOL, SODIUM CITRATE, TOCOPHEROL, PENTYLENE GLYCOL, MALTODEXTRIN, SUCROSE DILAURATE, SODIUM COCOYL GLUTAMATE, PHENOXYETHANOL, ETHYLPARABEN, METHYLPARABEN

Principal Display Panel

Almay

ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20

1 oz/ 30mL

INGREDIENTS AND APPEARANCE

ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20

titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0311-0710
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.4 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NIACINAMIDE (UNII: 25X51I8RD4)
PEA (UNII: W4X7H8GYFM)
SOYBEAN (UNII: L7HT8F1ZOD)
ALMOND (UNII: 3Z252A2K9G)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
LAURETH-7 (UNII: Z95S6G8201)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYSILICONE-15 (UNII: F8DRP5BB29)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
EDETATE SODIUM (UNII: MP1J8420LU)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE DILAURATE (UNII: 5926LC4S7M)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
LAMINARIA JAPONICA (UNII: WE98HW412B)
NEREOCYSTIS LUETKEANA (UNII: 3PC632V63J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0311-0710-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/16/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/16/2016

Labeler - Almay, Inc. (064988652)

Name	Address	ID/FEI	Business Operations
Establishment
REVLON, INC.		809725570	manufacture(0311-0710)

Revised: 10/2019

Document Id: 9586054e-7c80-da13-e053-2a95a90a96e5

Set id: 4418b335-80e8-1395-e054-00144ff88e88

Version: 2

Effective Time: 20191022