BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 DARK 03 - octinoxate and titanium dioxide cream 
Burberry Limited

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.

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BURBERRY FRESH GLOW B.B. CREAM LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 DARK 03

BURBERRY FRESH GLOW B.B. CREAM LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 DARK 03


Active ingredients

Octinoxate 6%
Titanium dioxide 2%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early 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 min before sun exposure
  • Reapply at least every 2 hrs
  • Use a water resistant sunscreen if swimming or sweating
  • Sun 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 10am-2pm
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

  • Protect the product in this container from excessive heat and direct sun.
  • Store container in upright position.

Inactive ingredients

water, diethylhexyl carbonate, ethylhexyl stearate, diisostearoyl polyglyceryl-3 dimer dilinoleate, cyclopentasiloxane, microcrystalline wax, hydrogenated castor oil, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, silica, hexyl laurate, sodium chloride, phenoxyethanol, cetyl dimethicone, potassium sorbate, sodium dehydroacetate, dimethicone, corn oil, nylon-12 fluorescent brightener 230 salt, propylene glycol dicaprylate/dicaprate, caprylic/capric triglyceride, tetrasodium EDTA, fragrance, hydrogenated vegetable oil, ascorbyl palmitate, tea (camellia sinensis) leaf extract, tocopheryl acetate, aminomethyl propanol, alpha-isomethyl ionone, polyvinylalcohol crosspolymer, spanish lavender (lavandula stoechas) extract, BHT, benzyl benzoate, hydroxycitronellal, dog rose (rosa canina) fruit extract, mica, titanium dioxide, iron oxides.

BURBERRY FRESH GLOW B.B. CREAM LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 DARK 03 30ml (69038-003-00)

Burberry Dark 30ml TubeBurberry Dark 30ml

BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 DARK 03 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:69038-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE60 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIETHYLHEXYL CARBONATE 
ETHYLHEXYL STEARATE 
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE 
CYCLOMETHICONE 5 
MICROCRYSTALLINE WAX 
HYDROGENATED CASTOR OIL 
POLYGLYCERYL-4 ISOSTEARATE 
SILICON DIOXIDE 
HEXYL LAURATE 
SODIUM CHLORIDE 
PHENOXYETHANOL 
POTASSIUM SORBATE 
SODIUM DEHYDROACETATE 
DIMETHICONE 
CORN OIL 
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE 
MEDIUM-CHAIN TRIGLYCERIDES 
EDETATE SODIUM 
ASCORBYL PALMITATE 
GREEN TEA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
AMINOMETHYLPROPANOL 
ISOMETHYL-.ALPHA.-IONONE 
LAVANDULA STOECHAS WHOLE 
BUTYLATED HYDROXYTOLUENE 
BENZYL BENZOATE 
HYDROXYCITRONELLAL 
ROSA CANINA FRUIT 
MICA 
FERRIC OXIDE RED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69038-003-001 in 1 CARTON
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/16/2014
Labeler - Burberry Limited (210047627)
Establishment
NameAddressID/FEIBusiness Operations
Intercos Europe S.p.A.438961310manufacture(69038-003)
Establishment
NameAddressID/FEIBusiness Operations
Intercos Europe S.p.A.339447428manufacture(69038-003)

Revised: 6/2014
 
Burberry Limited