BENEFIT HELLO HAPPY SOFT BLUR FOUNDATION SPF 15 SHADE 1- octinoxate, titanium dioxide lotion

Benefit Hello Happy Soft Blur Foundation SPF 15 by

Drug Labeling and Warnings

Benefit Hello Happy Soft Blur Foundation SPF 15 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 5.00%

TITANIUM DIOXIDE 2.06%

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 a 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), Phenyl Trimethicone, Alcohol Denat., Dimethicone, Isododecane, Silica, Butylene Glycol, Peg-10 Dimethicone, Methyl Methacrylate Crosspolymer, Polymethylsilsesquioxane, Mica, Sodium Chloride, Dimethicone/Peg-10/15 Crosspolymer, Isohexadecane, Squalane, Potassium Sorbate, Sodium Dehydroacetate, Disodium Stearoyl Glutamate, Tocopheryl Acetate, Isopropyl Titanium Triisostearate, Aluminum Hydroxide, Dipropylene Glycol, Butyrospermum Parkii (Shea) Seedcake Extract, Sodium Citrate, Tocopherol. [+/-: CI 77163 (Bismuth Oxychloride), CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide)].

Package Labeling:

Updated Labels:

INGREDIENTS AND APPEARANCE

BENEFIT HELLO HAPPY SOFT BLUR FOUNDATION SPF 15  SHADE 1
octinoxate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66472-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
MICA (UNII: V8A1AW0880)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOHEXADECANE (UNII: 918X1OUF1E)
SQUALANE (UNII: GW89575KF9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
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: 66472-044-01	1 in 1 CARTON	05/14/2018
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 66472-044-03	1 in 1 CARTON	05/14/2018
2		6 mL in 1 BOTTLE; 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	05/14/2018

Labeler - Benefit Cosmetics, LLC (070826813)