Label: BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM 02- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69038-002-00 - Packager: Burberry Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 13, 2014
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- Official Label (Printer Friendly)
- BURBERRY FRESH GLOW B.B. CREAM LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM 02
- Active ingredients
- Uses
- Warnings
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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
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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 MEDIUM 02 30ml (69038-002-00)
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INGREDIENTS AND APPEARANCE
BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM 02
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69038-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 60 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69038-002-00 1 in 1 CARTON 1 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/16/2014 Labeler - Burberry Limited (210047627) Establishment Name Address ID/FEI Business Operations Intercos Europe S.p.A. 438961310 manufacture(69038-002) Establishment Name Address ID/FEI Business Operations Intercos Europe S.p.A. 339447428 manufacture(69038-002)
