ALMAY HEALTH GLOW 3-IN-1 MAKEUP SPF 20- octinoxate, titanium dioxide, zinc oxide kit

Almay Health Glow 3-In-1 Makeup SPF 20 by

Drug Labeling and Warnings

Almay Health Glow 3-In-1 Makeup 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 - 7.0%

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/20/2016

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

Labeler - Almay, Inc. (064988652)

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