BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 OCHRE NUDE NO.12- avobenzone, octinoxate, octisalate cream 
Burberry Limited

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.

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Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre Nude No.12

Drug Facts

Active ingredients

Avobenzone 3.0%

Octinoxate 3.5%

Octisalate 4%

Purpose

Sunscreen

Uses

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

Other information

Inactive ingredients

Water, methyl trimethicone, isododecane, cyclopentasiloxane, butylene glycol, diphenyl dimethicone/vinyl diphenyl dimethicone/vinyl diphenyl dimethicone/silsesquioxane cross polymer, methyl methacrylate crosspolymer, PEG-10 dimethicone, phenyl trimethicone, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, glycerin, PEG/PPG-18/18 dimethicone, caprylyl methicone, sodium chloride, octyldodecanol, alcohol, acrylates/dimethicone copolymer, VP/VA copolymer, phenoxyethanol, 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, iron oxides, bismuth oxycholride.

Product Label

OchreNude_InnerOchreNude_Outer

BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 OCHRE NUDE NO.12 
avobenzone, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69038-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE35 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69038-027-001 in 1 CARTON06/23/2015
130 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/2015
Labeler - Burberry Limited (210047627)

Revised: 12/2017
Document Id: 616a5f3a-9e18-4834-e053-2a91aa0a2406
Set id: 1271830f-15fe-4e2b-aac1-0b068119553b
Version: 3
Effective Time: 20171228
 
Burberry Limited