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

Almay Wake-Up Liquid Make-Up by

Drug Labeling and Warnings

Almay Wake-Up Liquid Make-Up 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:

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0311-0704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0311-0704-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/23/2013

Labeler - Almay, Inc. (064988652)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(0311-0704)