BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01- octinoxate, titanium dioxide cream

BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01 by

Drug Labeling and Warnings

BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01 by is a Otc medication manufactured, distributed, or labeled by Burberry Limited, Intercos Europe S.p.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BURBERRY FRESH GLOW B.B. CREAM LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01

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 FAIR 01 30ml (

69038-001-00)

INGREDIENTS AND APPEARANCE

BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01  
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69038-001
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: 69038-001-00	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(69038-001)

Establishment
Name	Address	ID/FEI	Business Operations
Intercos Europe S.p.A.		339447428	manufacture(69038-001)