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

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

Other information

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 DRUGItem Code (Source)NDC:69038-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CORN OIL (UNII: 8470G57WFM)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LAVANDULA STOECHAS WHOLE (UNII: MTZ2ZA34ZV)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BENZYL BENZOATE (UNII: N863NB338G)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
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: 11/2014
Document Id: 7a663802-c4ed-4d24-bfa5-fe1e9d76a3d2
Set id: 1c59a72f-9de0-47c2-adee-3f09169eaae3
Version: 3
Effective Time: 20141113
 
Burberry Limited