TOO FACED HANGOVER GOOD TO GO SPF 25 BROAD SPECTRUM MOISTURIZER- avobenzone, homosalate, octisalate, and octocrylene lotion

TOO FACED HANGOVER GOOD TO GO SPF 25 BROAD SPECTRUM MOISTURIZER by

Drug Labeling and Warnings

TOO FACED HANGOVER GOOD TO GO SPF 25 BROAD SPECTRUM MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by TOO FACED COSMETICS LLC, Estee Lauder Companies Inc., MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Avobenzone 3%
Homosalate 8%
Octisalate 5%
Octocrylene 8%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use 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 rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply generously and evenly 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• 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 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

Water\Aqua\Eau, C12-15 Alkyl Benzoate, Glycerin, Octyldodecyl Neopentanoate, Butylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Cinnamomum Zeylanicum Bark Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Acetate, Beeswax\Cera Alba\Cire D'abeille, Ethylhexylglycerin, Inulin, Lactobacillus Ferment, Octyldodecanol, Sarcosine, Yogurt Powder, Cellulose, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capryloyl Glycine, Steareth-20, Hydroxyethylcellulose, Hexylene Glycol, Citric Acid, Sodium Hydroxide, Fragrance (Parfum), Cocos Nucifera (Coconut) Water, Disodium EDTA, Tetrahexyldecyl Ascorbate, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate <ILN45850>

Other information

protect the product in this container from excessive heat and direct sun

Questions?

toofaced.com

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton

Too
Faced

HYDRATING LIGHTWEIGHT

HANGOVERx
GOOD to GO

Coconut Water
Prebiotic & Probiotic Based Ingredients

SKIN PROTECTING
SPF 25
MOISTURIZER

Broad Spectrum SPF 25
protects against
UVA & UVB rays

40 mL / 1.4 Fl. Oz.

INGREDIENTS AND APPEARANCE

TOO FACED HANGOVER GOOD TO GO SPF 25 BROAD SPECTRUM MOISTURIZER 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79596-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0306 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.0816 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.051 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.0816 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Glycerin (UNII: PDC6A3C0OX)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Butylene Glycol (UNII: 3XUS85K0RA)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cinnamon Bark Oil (UNII: XE54U569EC)
Jojoba Oil (UNII: 724GKU717M)
Sodium Acetate (UNII: 4550K0SC9B)
Ethylhexylglycerin (UNII: 147D247K3P)
Inulin (UNII: JOS53KRJ01)
Lactobacillus Reuteri (UNII: 9913I24QEE)
Octyldodecanol (UNII: 461N1O614Y)
Sarcosine (UNII: Z711V88R5F)
Powdered Cellulose (UNII: SMD1X3XO9M)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Capryloyl Glycine (UNII: 8TY5YO42NJ)
Steareth-20 (UNII: L0Q8IK9E08)
Hexylene Glycol (UNII: KEH0A3F75J)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Hydroxide (UNII: 55X04QC32I)
Coconut Water (UNII: 267F5Y81NT)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79596-005-01	1 in 1 CARTON	06/15/2019
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/15/2019

Labeler - TOO FACED COSMETICS LLC (014131481)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(79596-005) , REPACK(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(79596-005) , REPACK(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(79596-005) , REPACK(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(79596-005)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		078870292	MANUFACTURE(79596-005)