BENEFIT HELLO HAPPY FLAWLESS BRIGHTENING FOUNDATION SPF15 SHADE 2- octinoxate, titanium dioxide cream

Benefit Hello Happy Flawless Brightening Foundation SPF15 by

Drug Labeling and Warnings

Benefit Hello Happy Flawless Brightening Foundation SPF15 by is a Otc medication manufactured, distributed, or labeled by Benefit Cosmetics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

OCTINOXATE 3.00%

TITANIUM DIOXIDE 4.02%

Purpose

SUNSCREEN

Use

• 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 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 swallowed, get medical help or contact Poison Control center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: ask a doctor.
• Skin 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. till 2 p.m.
• Wear long-sleeved shirts, pants, hats & sunglasses.

Other information

Protect the product in this container from excessive heat or direct sun.

Inactive ingredients

Aqua (Water), Methyl Trimethicone, Alcohol, Isododecane, Phenyl Trimethicone, Peg-9 Polydimethylsiloxyethyl Dimethicone, Acrylates/Dimethicone Copolymer, Diphenyl Dimethicone/ Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Glycerin,  Dimethiconol/Methylsilanol/Silicate Crosspolymer, Silica, Aluminum Hydroxide, Dimethicone, Phenoxyethanol, Synthetic Fluorphlogopite, Stearic Acid, Sodium Myristoyl Glutamate, Glyceryl Undecyl Dimethicone, Disteardimonium Hectorite, Vp/Va Copolymer, Silica Silylate, Propylene Carbonate, Sodium Metabisulfite, Sodium Tocopheryl Phosphate, Hyaluronic Acid, Hydrogen Dimethicone, Sodium Hyaluronate, Bht, Hibiscus Sabdariffa Flower Extract. [+/-: CI 77163 (Bismuth Oxychloride), CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide)].

Package Labeling:

Package Labeling: (

66472-057-02)

Package Labeling: (

66472-057-03)

INGREDIENTS AND APPEARANCE

BENEFIT HELLO HAPPY FLAWLESS BRIGHTENING FOUNDATION SPF15   SHADE 2
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66472-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ALCOHOL (UNII: 3K9958V90M)
ISODODECANE (UNII: A8289P68Y2)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYALURONIC ACID (UNII: S270N0TRQY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66472-057-01	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/01/2019
2	NDC: 66472-057-02	3 mL in 1 VIAL; Type 0: Not a Combination Product	08/04/2019
3	NDC: 66472-057-03	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2019

Labeler - Benefit Cosmetics, LLC (070826813)