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HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im Hopelessly Hot

Dosage form: cream
Ingredients: OCTINOXATE 54.9mg in 1mL, TITANIUM DIOXIDE 23.7mg in 1mL
Labeler: Benefit Cosmetics, LLC
NDC Code: 66472-027

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im Hopelessly Hot

HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im Hopelessly Hot


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.

WarningsFor 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 IngredientsAqua (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)

HELLO FLAWLESS OIL-FREE OXYGEN WOW BROAD SPECTRUM SPF 25 BRIGHTENING SUNSCREEN MAKEUP benefit 1.0 fl oz (30 mL) OXYGEN WOW HYDRATING COMPLEX BRIGHTENING OIL-FREE FLAWLESS

HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im Hopelessly Hot (66472-027-01)









HELLO FLAWLESS OXYGEN WOW BROAD SPECTRUM SPF 25 BRIGHTENING MAKEUP - IM HOPELESSLY HOT 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66472-027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE54.9 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE23.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
GLYCERIN 
ISODODECANE 
PHENYL TRIMETHICONE 
BUTYLENE GLYCOL 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
PENTYLENE GLYCOL 
SODIUM CHLORIDE  
PHENOXYETHANOL 
CHONDRUS CRISPUS 
SILICON DIOXIDE 
STEARIC ACID 
SODIUM MYRISTOYL GLUTAMATE 
ALUMINUM OXIDE 
.ALPHA.-TOCOPHEROL ACETATE 
PROPYLENE CARBONATE 
PROLINAMIDOETHYL IMIDAZOLE 
SACCHAROMYCES LYSATE 
ALUMINUM HYDROXIDE 
ASCORBYL TETRAISOPALMITATE 
BUTYLATED HYDROXYTOLUENE 
MICA 
ULTRAMARINE BLUE 
BISMUTH OXYCHLORIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:66472-027-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/20/2011
Labeler - Benefit Cosmetics, LLC (070826813)
Establishment
NameAddressID/FEIOperations
Parfums Christian Dior396393746manufacture(66472-027)

Revised: 12/2012
Document Id: e7ddebed-3b7c-434e-b579-c54c06c8ffee
Set id: b7593793-c2d2-449b-b30a-efd67f827e4a
Version: 4
Effective Time: 20121207
 
Benefit Cosmetics, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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