FDA.reportPublic FDA data

Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50

Manufacturer
Taylor James, LTD | Bell Pharmaceuticals
Effective date
2017-01-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:48:37

Label at a glance#

ProductDefense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50 Supergoop
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients     Purpose

Avobenzone 3%      Sunscreen

Homosalate 4%      Sunscreen

Octinoxate 6%       Sunscreen

Octisalate 3%        Sunscreen           

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

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

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

DOSAGE & ADMINISTRATION SECTION

Directions Apply 15 minutes prior to sun exposure

Use a water resistant if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Defense Refresh Setting Mist

With Rosemary

Broad Spectrum Sunscreen SPF 50

Matte finish three in one

sets make-up, controls oil and delivers UV photoaging protection

labellabel

boxbox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-133-022022-01-28C16284748780-1d6a99b39-339f-a426-e053-dadaa90af4c2Defense Refresh Setting Mist Broad Spectrum Sunscreen SPF 50
75936-133-042022-01-28C16284748780-1d6a99b39-339f-a426-e053-dadaa90af4c2Defense Refresh Setting Mist Broad Spectrum Sunscreen SPF 50
75936-133-062022-01-28C16284748780-1d6a99b39-339f-a426-e053-dadaa90af4c2Defense Refresh Setting Mist Broad Spectrum Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-133-01Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50Supergoop100 mL in 1 BOTTLE, SPRAYLIQUID1006
75936-133-02Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50Supergoop1 in 1 BOXLIQUID16
75936-133-03Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50Supergoop30 mL in 1 BOTTLE, SPRAYLIQUID306
75936-133-04Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50Supergoop1 in 1 BOXLIQUID16
75936-133-05Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50Supergoop15 mL in 1 BOTTLE, SPRAYLIQUID156
75936-133-06Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50Supergoop1 in 1 BOXLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-133DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) LIQUID [TAYLOR JAMES, LTD]6Legacy NDC, 6 package rows20170124_efe3f7b3-e0ca-4550-972d-a90f31f2295d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX3
HOMOSALATEACTIVE INGREDIENTV06SV4M95S3
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513
OCTISALATEACTIVE INGREDIENT4X49Y0596W3
AVOBENZONEACTIVE MOIETYG63QQF2NOX3
HOMOSALATEACTIVE MOIETYV06SV4M95S3
OCTINOXATEACTIVE MOIETY4Y5P7MUD513
OCTISALATEACTIVE MOIETY4X49Y0596W3
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D33
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA3
ISODODECANEINACTIVE INGREDIENTA8289P68Y23
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH3
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3933
SPEARMINT OILINACTIVE INGREDIENTC3M81465G53
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75936-13375936-133-01, 75936-133-02, 75936-133-03, 75936-133-04, 75936-133-05, 75936-133-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ALCOHOL3K9958V90MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ISODODECANEA8289P68Y2IACT
PEPPERMINT OILAV092KU4JHIACT
SPEARMINT OILC3M81465G5IACT
ROSEMARY OIL8LGU7VM393IACT
WATER059QF0KO0RIACT

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 2 · 105 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5CAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5SYRUP / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
SPEARMINT OILSPEARMINT OILC3M81465G5TABLET / SUBLINGUAL0.4 mgExact identifier — unii candidate
7 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 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
bb620cdd-d784-4a9b-b282-84c85d39618defe3f7b3-e0ca-4550-972d-a90f31f2295d2017-01-23WarningsExact identifier
spl id: bb620cdd-d784-4a9b-b282-84c85d39618d
spl set id: efe3f7b3-e0ca-4550-972d-a90f31f2295d

Reported adverse events (FAERS/openFDA)#

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