Drug Facts

Active ingredients

Octinoxate 3.49%

Octisalate 4.00%

Purpose

Sunscreen

Uses

Helps Prevent Sunburn.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin 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

Reapp ly at least every 2 hrs.
Use a water resistant sunscreen if swimming or sweating.
Apply liberal ly 15 mins before sun exposure.
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, Methyl Trimethicone, Isododecane, Cyclopentasiloxane, Butylene Glycol, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Glycerin, Sodium Chloride, Octyldodecanol, Alcohol, Acrylates/Dimethicone Copolymer, VP/VA Copolymer, Caprylyl Methicone, Phenoxyethanol, Triethyl Citrate, Disteardimonium Hectorite, Caprylyl Glycol, Tocopheryl Acetate, Triethoxycaprylylsilane, Propylene Carbonate, Disodium EDTA, Gum Arabic Tree (Acacia Senegal) Gum, Xanthan Gum, Sodium Hyaluronate, Dog Rose (Rosa Canina) Fruit Extract, BHT, Tea (Camellia Sinensis) Leaf Extract, Citric Acid, Tocopherol, Sodium Benzoate, Potassium Sorbate, Spanish Lavender (Lavandula Stoechas) Extract. May Contain: Titanium Dioxide, Bismuth Oxychloride, Iron Oxides.

Package Labeling

Rosy nude no.31

BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN SPF20 ROSY NUDE
octinoxate, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69038-044
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	34.9 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ISODODECANE (UNII: A8289P68Y2)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
ALCOHOL (UNII: 3K9958V90M)
PVP/VA COPOLYMER (UNII: D9C330MD8B)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TEA LEAF (UNII: GH42T47V24)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69038-044-30	1 in 1 PACKAGE	11/07/2015
1		30 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/07/2015

Labeler - Burberry Limited (210047627)

Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Rosy Nude No. 31