ALMAY WAKE-UP LIQUID MAKE-UP- titanium dioxide, oxctinoxate liquid 
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.

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Almay Wake-Up Liquid Make-Up

Active Ingredients:

Titanium Dioxide: 9.0%

Octinoxate 3.5%

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), Dimethicone, Neopentyl Glycol Diheptanoate, Butylene Glycol, Glycerin, Isostearic Acid, Phenyl Trimethicone, Isocetyl Stearate, Isotridecyl Isononanoate, Tromethamine, Pentaerythrityl Tetraisostearate, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Viola Tricolor Extract, Lecithin, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf (Green Tea) Extract, Cocos Nucifera (Coconut) Water, Caffeine, Nylon-12, Steareth-2, Glyceryl Stearate, Alumina, Propylene Glycol Laurate, Propylene Glycol Stearate, Simethicone, Sorbitan Laurate, Polysorbate 20, Laureth-7, Xanthan Gum, Methicone, C13-14 Isoparaffin, Steareth-21, Stearic Acid, Polyacrylamide, Potassium Sorbate, Caprylyl Glycol, 1,2-Hexanediol

Principal Display Panel

Almay

Almay Wake-Up Liquid Make-Up

1 oz/ 30mL

Label

ALMAY WAKE-UP LIQUID MAKE-UP 
titanium dioxide, oxctinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0704
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
NYLON-12 (UNII: 446U8J075B)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
TROMETHAMINE (UNII: 023C2WHX2V)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CUCUMBER (UNII: YY7C30VXJT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCONUT (UNII: 3RT3536DHY)  
CAFFEINE (UNII: 3G6A5W338E)  
STEARETH-2 (UNII: V56DFE46J5)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)  
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
PEG-10 SORBITAN LAURATE (UNII: 4Z93U4C2WN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
LAURETH-7 (UNII: Z95S6G8201)  
XANTHAN GUM (UNII: TTV12P4NEE)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0311-0704-0130 mL in 1 TUBE; Type 0: Not a Combination Product04/23/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/23/2013
Labeler - Almay, Inc. (064988652)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(0311-0704)

Revised: 12/2016
Document Id: 44071c8d-ea8f-23f8-e054-00144ff88e88
Set id: 44071c8d-ea8e-23f8-e054-00144ff88e88
Version: 1
Effective Time: 20161219
 
Almay, Inc.