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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Almay Health Glow 3-In-1 Makeup SPF 20

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

Label

ALMAY HEALTH GLOW 3-IN-1 MAKEUP SPF 20 
octinoxate, titanium dioxide, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0711
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0311-0711-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package01/20/2016
Quantity of Parts
Part #Package QuantityTotal 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.128 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.275 mg
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mg
Inactive Ingredients
Ingredient NameStrength
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/20/2016
Part 2 of 2
ALMAY HEALTH GLOW 3-1 SELF TANNER 
suntan gels, creams, and liquids liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRDIHYDROXYACETONE (UNII: O10DDW6JOO)  
INGRPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPOLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
INGRTRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRCARAMEL (UNII: T9D99G2B1R)  
INGRETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRSODIUM CITRATE (UNII: 1Q73Q2JULR)  
INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/20/2016
Labeler - Almay, Inc. (064988652)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(0311-0711)

Revised: 10/2019
Document Id: 95860633-2b52-eb44-e053-2995a90afcc4
Set id: 4e1d19e1-eef7-45d5-b250-8426a5488317
Version: 2
Effective Time: 20191022
 
Almay, Inc.