AVOBENZONE, OCTINOXATE, OCTISALATE

Manufacturer
Burberry Limited
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:53:49

Label at a glance#

ProductBurberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Dark Sable No.36
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE
Label structure7 sections

Indications and 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.

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Octinoxate 3.5%

Octisalate 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, methyl trimethicone, isododecane, cyclopentasiloxane, butylene glycol, diphenyl dimethicone/vinyl 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, 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 oxieds, bismuth oxychloride.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DarkSable_InnerDarkSable_InnerDarkSable_OuterDarkSable_Outer

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69038-022-00Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Dark Sable No.361 in 1 CARTONCREAM13
69038-022-00Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Dark Sable No.3630 mL in 1 PACKAGECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69038-022BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 DARK SABLE NO.36 (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [BURBERRY LIMITED]3Legacy NDC, 2 package rows20171228_f6002b2f-3ae1-4594-b5ed-6645cfaaa09e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ACACIAINACTIVE INGREDIENT5C5403N26O2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
BISMUTH OXYCHLORIDEINACTIVE INGREDIENT4ZR792I5872
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CAPRYLYL TRISILOXANEINACTIVE INGREDIENTQ95M2P1KJL2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8B2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH2
ISODODECANEINACTIVE INGREDIENTA8289P68Y22
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEINACTIVE INGREDIENT25G622K2RA2
LAVANDULA STOECHAS FLOWERING TOPINACTIVE INGREDIENT70759G2U6A2
METHYL TRIMETHICONEINACTIVE INGREDIENTS73ZQI0GXM2
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y2
PEG/PPG-18/18 DIMETHICONEINACTIVE INGREDIENT9H0AO7T7942
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ42
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
TEA LEAFINACTIVE INGREDIENTGH42T47V242
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69038-02269038-022-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 12 · 680 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRATHECAL131 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XIMPLANT / SUBCUTANEOUS77 mgExact identifier — unii candidate
134 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii candidate
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR45 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XENEMA / RECTAL0.7 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER / TOPICALNAExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE / ORAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ORAL1126 mgExact identifier — unii candidate
134 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / RECTAL6.67 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii candidate
19 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii candidate
134 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii candidate
134 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BCAPSULE, DELAYED RELEASE / ORAL199 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET, DELAYED RELEASE / ORAL168 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
ACACIAACACIA5C5403N26OSYRUP / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
616a5a44-2f28-1ed0-e053-2991aa0a7b16f6002b2f-3ae1-4594-b5ed-6645cfaaa09e2017-12-28WarningsExact identifier
spl id: 616a5a44-2f28-1ed0-e053-2991aa0a7b16
spl set id: f6002b2f-3ae1-4594-b5ed-6645cfaaa09e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.