BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN SPF20 ALMOND

Main information

  • Trade name:
  • BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN SPF20 ALMOND- octinoxate, octinoxate cream
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN SPF20 ALMOND- octinoxate, octinoxate cream
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • - Helps Prevent Sunburn.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 69038-036-30
  • Last update:
  • 01-06-2019

Summary of Product characteristics: dosage, interactions, side effects

BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION

SUNSCREEN SPF20 ALMOND- octinoxate, octinoxate 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.

----------

Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Almond

No. 43

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, Cyclopentasiloxane, Methyl Trimethicone, Butylene Glycol, PEG/PPG-18/18 Dimethicone,

Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Methyl

Methacrylate Crosspolymer, Phenyl Trimethicone, PEG-10 Dimethicone, Lauryl PEG-9

Polydimethylsiloxyethyl Dimethicone, Glycerin, Sodium Chloride, Isododecane, Octyldodecanol,

Alcohol, Acrylates/Dimethicone Copolymer, VP/VA Copolymer, Caprylyl Methicone, Phenoxyethanol,

Triethyl Citrate, 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, Sodium Benzoate, Tocopherol, Potassium Sorbate,

Spanish Lavender (Lavandula Stoechas) Extract. May Contain: Titanium Dioxide, Bismuth

Oxychloride, Iron Oxides.

Package Labeling

BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE

FOUNDATION SUNSCREEN SPF20 ALMOND

octinoxate, octinoxate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 0 38 -0 36

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

34.9 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

40 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

WATER (UNII: 0 59 QF0 KO0 R)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

METHYL TRIMETHICO NE (UNII: S73ZQI0 GXM)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

PEG/PPG-18 /18 DIMETHICO NE (UNII: 9 H0 AO7T79 4)

PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R)

LAURYL PEG-9 PO LYDIMETHYLSILO XYETHYL DIMETHICO NE (UNII: 25G6 22K2RA)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

Burberry Limited

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

CAPRYLYL TRISILO XANE (UNII: Q9 5M2P1KJL)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

XANTHAN GUM (UNII: TTV12P4NEE)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

TEA LEAF (UNII: GH42T47V24)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 0 38 -0 36 -30

1 in 1 PACKAGE

11/0 7/20 15

1

30 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

11/0 7/20 15

Labeler -

Burberry Limited (210047627)

Revised: 12/2017