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NDC 00311-0711-01 Almay Health Glow 3-In-1 Makeup SPF 20 Details

Almay Health Glow 3-In-1 Makeup SPF 20

Almay Health Glow 3-In-1 Makeup SPF 20 is a TOPICAL KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Almay, Inc.. The primary component is .

Product Information

NDC	00311-0711
Product ID	0311-0711_95860633-2b52-eb44-e053-2995a90afcc4
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 Health Glow 3-In-1 Makeup SPF 20
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate, Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	TOPICAL
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
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 00311-0711-01 (00311071101)

Pricing Information	N/A
NDC Package Code	0311-0711-01
Billing NDC	00311071101
Package	1 KIT in 1 PACKAGE (0311-0711-01)
Marketing Start Date	2016-01-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4e1d19e1-eef7-45d5-b250-8426a5488317 Details

Active Ingredients:

Octinoxate - 7.0%

Titanium Dioxide 7.1%

Zinc Oxide 4.2%

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

AQUA (WATER (EAU)), CYCLOPENTASILOXANE, DIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PHENYL TRIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, GLYCERIN, BORON NITRIDE, TRIMETHYLSILOXYSILICATE, ALUMINA, DIMETHICONE/PEG-10/15 CROSSPOLYMER, BUTYLENE GLYCOL, SODIUM CHLORIDE, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, METHICONE, XANTHAN GUM, METHYLPARABEN, ETHYLPARABEN, TETRASODIUM EDTA, TOCOPHERYL ACETATE, DIPROPYLENE GLYCOL, SODIUM CITRATE, TOCOPHEROL, MELANIN, PENTYLENE GLYCOL

Principal Display Panel

Almay

Almay Health Glow 3-In-1 Makeup SPF 20

INGREDIENTS AND APPEARANCE

ALMAY HEALTH GLOW 3-IN-1 MAKEUP SPF 20

octinoxate, titanium dioxide, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0311-0711

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0311-0711-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	01/20/2016

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1		1
Part 2		1

Part 1 of 2
ALMAY HEALTH GLOW 3-IN-1 MAKEUP octinoxate, titanium dioxide, zinc oxide liquid

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.128 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.275 mg
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 mg

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERIN (UNII: PDC6A3C0OX)
BORON NITRIDE (UNII: 2U4T60A6YD)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
METHICONE (20 CST) (UNII: 6777U11MKT)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE SODIUM (UNII: MP1J8420LU)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/20/2016

Part 2 of 2
ALMAY HEALTH GLOW 3-1 SELF TANNER suntan gels, creams, and liquids liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	DIHYDROXYACETONE (UNII: O10DDW6JOO)
INGR	PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
INGR	TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	CARAMEL (UNII: T9D99G2B1R)
INGR	ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	SODIUM METABISULFITE (UNII: 4VON5FNS3C)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	SODIUM CITRATE (UNII: 1Q73Q2JULR)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/20/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/20/2016

Labeler - Almay, Inc. (064988652)

Name	Address	ID/FEI	Business Operations
Establishment
REVLON, INC.		809725570	manufacture(0311-0711)

Revised: 10/2019

Document Id: 95860633-2b52-eb44-e053-2995a90afcc4

Set id: 4e1d19e1-eef7-45d5-b250-8426a5488317

Version: 2

Effective Time: 20191022

Search by Drug Name or NDC

NDC 00311-0711-01 Almay Health Glow 3-In-1 Makeup SPF 20 Details

Almay Health Glow 3-In-1 Makeup SPF 20

Product Information

Package

Package Images

NDC 00311-0711-01 (00311071101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4e1d19e1-eef7-45d5-b250-8426a5488317 Details

Active Ingredients:

Purpose

Uses:

Warnings:

Directions

Sun Protection Measures

Inactive Ingredients

Principal Display Panel

INGREDIENTS AND APPEARANCE

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