BURBERRY FRESH GLOW FOUNDATION LUMINOUS FLUID PORCELAIN NO. 11- octinoxate cream

Burberry Fresh Glow Foundation Luminous Fluid Porcelain No. 11 by

Drug Labeling and Warnings

Burberry Fresh Glow Foundation Luminous Fluid Porcelain No. 11 by is a Otc medication manufactured, distributed, or labeled by Burberry Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active Ingredients

Octinoxate 7%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and earlyskin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging   

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 mins before sun exposure.
• Reapply at least every 2 hrs.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor.

Other information

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

Inactive ingredients

water, dimethicone, cyclopentasiloxane, peg-10 dimethicone, propanediol, aluminium starch octenylsuccinate, mica, phenoxyethanol, sodium chloride, disteardimonium hectorite, disodium stearoyl glutamate, dimethicone crosspolymer, tocopheryl acetate, ethylhexylglycerin, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, hexyl laurate, alcohol denat. (sd alcohol 40-b), tea (camellia sinensis) leaf extract, caprylic/capric triglyceride, panthenol, glycerin, sodium hyaluronate, aluminium hydroxide, BHT, spanish lavender (lavandula stoechas) extract, dog rose (rosa canina) fruit extract, pantolactone, phenethyl alcohol, tocopherol, pantaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, rutin, titanium dioxide, iron oxides

SPL UNCLASSIFIED SECTION

Manufactured for Burberry Limited  Horseferry House  Horseferry Road  London SW1P2AW  Made In France  Burberry.com

You May Report Serious  Adverse Events to: 444 Madison Avenue  New York, NY 10022

PRINCIPAL DISPLAY PANEL

PORCELAIN No.11 BURBERRY  FRESH GLOW FOUNDATION   LUMINOUS FLUID FOUNDATION  SUNSCREEN BROAD SPECTRUM SPF 12   1 FL OZ  (30 ML)

Product Label

INGREDIENTS AND APPEARANCE

BURBERRY FRESH GLOW FOUNDATION LUMINOUS FLUID PORCELAIN NO. 11 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69038-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TEA LEAF (UNII: GH42T47V24)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
PANTOLACTONE, (R)- (UNII: J288D7O0JS)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
RUTIN (UNII: 5G06TVY3R7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69038-014-00	1 in 1 CARTON	11/14/2014
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69038-014-01	3 in 1 BOX	11/14/2014
2		1 in 1 CARTON
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/14/2014

Labeler - Burberry Limited (210047627)