BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 MOCHA NO.64- avobenzone, octinoxate, octisalate cream

Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 15 Mocha No.64 by

Drug Labeling and Warnings

Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 15 Mocha No.64 by is a Otc medication manufactured, distributed, or labeled by Burberry Limited, Shiseido International France S.A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3.0%

Octinoxate 3.5%

Octisalate 4%

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 skin 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 mins before sun exposure.
• Reapply at least every 2 hrs.
• Use a water resistant sunscreen if swiming 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 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses
• Children under 6 months of age:  Ask doctor.

Other information

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

Inactive ingredients

Water, cyclopentasiloxane, methyl trimethicone, butylene glycol, PEG/PPG-18/18 dimethicone, diphenyl dimethicone/vinyl diphenyl dimethicone/vinyl diphenyl dimethicone/silsesquioxane cross polymer, methyl methacrylate crosspolymer, phenyl trimethicone, PEG-10 dimethicone, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, glycerin, caprylyl methicone, sodium chloride, isododecane, octyldodecanol, alcohol, acrylates/dimethicone copolymer, VP/VA copolymer, phenoxyethanol, triethoxycaprylylsilane, tocopheryl acetate, caprylyl glycol, disteardimonium hectorite, disodium EDTA, propylene carbonate, 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, iron oxieds, bismuth oxychloride.

Product Label

INGREDIENTS AND APPEARANCE

BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 MOCHA NO.64 
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69038-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
ALCOHOL (UNII: 3K9958V90M)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ACACIA (UNII: 5C5403N26O)
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)
LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69038-025-00	1 in 1 CARTON
1		30 mL in 1 PACKAGE; 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	06/23/2015

Labeler - Burberry Limited (210047627)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido International France S.A.S.		504736831	manufacture(69038-025)