BENEFIT HELLO HAPPY AIR FOUNDATION SHADE 11- octinoxate, titanium dioxide stick

Benefit Hello Happy Air Foundation by

Drug Labeling and Warnings

Benefit Hello Happy Air Foundation 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 4.00%

TITANIUM DIOXIDE 2.36%

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

Hydrogenated Polyisobutene, Polyethylene, Synthetic Fluorphlogopite, Polymethyl Methacrylate, C12-15 Alkyl Ethylhexanoate, Butyrospermum Parkii (Shea) Butter, Cetyl Peg/ Ppg-10/1 Dimethicone, C20-40 Pareth-3, Caprylyl Glycol, Phenoxyethanol, Silica, Lauroyl Lysine, Bht, Tocopheryl Acetate, Fragrance (Parfum), Linalool, Ascorbyl Palmitate, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower/ Leaf/Stem Extract, Tocopherol, Geraniol, Limonene, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Citric Acid. [+/-: Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)].

Package Labeling:

INGREDIENTS AND APPEARANCE

BENEFIT HELLO HAPPY AIR FOUNDATION   SHADE 11
octinoxate, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66472-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)
SHEA BUTTER (UNII: K49155WL9Y)
C20-40 PARETH-3 (UNII: 68103A23TQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAUROYL LYSINE (UNII: 113171Q70B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
GINKGO (UNII: 19FUJ2C58T)
TOCOPHEROL (UNII: R0ZB2556P8)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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: 66472-079-01	8.5 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2020

Labeler - Benefit Cosmetics, LLC (070826813)