OTC Medication Information: Burberry Fresh Glow Foundation Luminous Fluid Almond No. 43

BURBERRY FRESH GLOW FOUNDATION LUMINOUS FLUID ALMOND NO. 43- 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.

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.

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

ALMOND No.43 BURBERRY FRESH GLOW FOUNDATION LUMINOUS FLUID FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 12 1 FL OZ (30 ML)

Product Label

AlmondNo43
(click image for full-size original)

BURBERRY FRESH GLOW FOUNDATION LUMINOUS FLUID ALMOND NO. 43
octinoxate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69038-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 70 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
CYCLOMETHICONE 5
PROPANEDIOL
ALUMINUM STARCH OCTENYLSUCCINATE
MICA
PHENOXYETHANOL
SODIUM CHLORIDE
DISTEARDIMONIUM HECTORITE
DISODIUM STEAROYL GLUTAMATE
.ALPHA.-TOCOPHEROL ACETATE
ETHYLHEXYLGLYCERIN
POLYGLYCERYL-4 ISOSTEARATE
HEXYL LAURATE
TEA LEAF
MEDIUM-CHAIN TRIGLYCERIDES
PANTHENOL
GLYCERIN
HYALURONATE SODIUM
ALUMINUM HYDROXIDE
BUTYLATED HYDROXYTOLUENE
ROSA CANINA FRUIT
PANTOLACTONE, (R)-
PHENYLETHYL ALCOHOL
TOCOPHEROL
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
RUTIN
TITANIUM DIOXIDE
FERRIC OXIDE RED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69038-004-00 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (69038-004-00)
2 NDC:69038-004-01 3 CARTON in 1 BOX contains a CARTON
2 1 BOTTLE in 1 CARTON This package is contained within the BOX (69038-004-01) and contains a BOTTLE
2 30 mL in 1 BOTTLE This package is contained within a CARTON and a BOX (69038-004-01)
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)

Revised: 09/2019 Burberry Limited

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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