AVOBENZONE, OCTINOXATE, OCTISALATE

Manufacturer
Burberry Limited | Shiseido International France S.A.S.
Effective date
2015-07-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:42:54

Label at a glance#

ProductBurberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre No.20
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 cross polymer, 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 oxides, bismuth oxycholride.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ochre20_InnerOchre20_InnerOchre20_OuterOchre20_Outer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69038-026-002020-01-31C16284748780-19d75b9d0-4633-f424-e053-dadaa90a57ceBurberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre No.20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69038-026-00Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre No.2030 mL in 1 PACKAGECREAM302
69038-026-00Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre No.201 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69038-026BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 OCHRE NO.20 (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [BURBERRY LIMITED]2Legacy NDC, 2 package rows20150702_50a555d2-76d5-46bd-aab4-5cda59f68d55.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
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
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R2
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
69038-02669038-026-00

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

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 11 · 648 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
16 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR360 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii candidate
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XIMPLANT / SUBCUTANEOUS77 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RESPIRATORY (INHALATION)108 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 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
62503376-016f-4b9d-990b-ad4da61b64a350a555d2-76d5-46bd-aab4-5cda59f68d552015-07-01WarningsExact identifier
spl id: 62503376-016f-4b9d-990b-ad4da61b64a3
spl set id: 50a555d2-76d5-46bd-aab4-5cda59f68d55

Reported adverse events (FAERS/openFDA)#

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