BENEFIT HELLO FLAWLESS OXYGEN WOW BROAD SPECTRUM SPF 25 BRIGHTENING MAKEUP - GOTTA KNOW ME- octinoxate, titanium dioxide cream

BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - GOTTA KNOW ME by

Drug Labeling and Warnings

BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - GOTTA KNOW ME by is a Otc medication manufactured, distributed, or labeled by Benefit Cosmetics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - GOTTA KNOW ME

SPL UNCLASSIFIED SECTION

Active Ingredients

Octinoxate 5.49%
Titanium Dioxide 2.37%

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 and sun glasses
  

Other information

Protect the product in this container from excessive heat or direct sun. Do not use if safety seals on unit carton are missing or broken.

Inactive Ingredients

Aqua (Water), Dimethicone, Glycerin, Isododecane, Phenyl Trimethicone, Peg-9 Polydimethylxetyl Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Pentylene Glycol, Mats Aqua (Sea Water), Phenoxyethanol, Chondrus Crispus (Carrageenan), Silica, Disteardimonium Hectorite, Stearic Acid, Sodium Myristoyl Glutamate, Alumina, Tocopheryl Acetate, Propylene Carbonate, Prolinamidoethyl Imidazole, Saccharomyces Lysate Extract, Aluminum Hydroxide, Ascorbyl Tetraisopalmitate, BHT, Mica, CI 77007, CI 77163 (Bismuth Oxychloride), CI 77491, CI 77492, CI 77499 (Iron Oxide), CI 77891 (Titanium Dioxide)

Package Labeling:

INGREDIENTS AND APPEARANCE

BENEFIT HELLO FLAWLESS OXYGEN WOW BROAD SPECTRUM SPF 25 BRIGHTENING MAKEUP - GOTTA KNOW ME 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66472-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	54.9 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROLINAMIDOETHYL IMIDAZOLE (UNII: 44U29L6P0T)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
ULTRAMARINE BLUE (UNII: I39WR998BI)
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: 66472-031-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/20/2011

Labeler - Benefit Cosmetics, LLC (070826813)