FDA.reportPublic FDA data

Burn Out SPF-30 Sunscreen

Manufacturer
Sun Research LLC
Effective date
2020-01-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:03:20

Label at a glance#

ProductBurn Out SPF-30 Sunscreen
Active ingredientZinc Oxide
Label structure10 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (non-nano) 20%

Purpose

OTC - PURPOSE SECTION

sunscreen

Use(s)

INDICATIONS & USAGE SECTION

  • Provides high protection against sunburn.
  • Provides broad spectrum (UVA and UVB) protection.
  • Retains SPF after 40 minutes of activity in the water or sweating.
  • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • Keep out of eyes. Rinse with water to remove.
  • Stop and ask a doctor if rash or irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
  • Children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Organic Aloe Barbadensis Leaf Juice1, Capric/ Caprylic Triglycerides, Sorbitan Stearate, Polyglyceryl-10 Laurate, Cetyl Dimethicone, Magnesium Sulfate, Organic Avocado Oil1, Virgin Hemp Seed Oil, Organic Cucumber Extract1, Organic Green Tea Extract1, Tocopherols, Organic Pomegranate Juice1, Helionori, Hyaluronic Acid, Ethylhexylglycerin, Hydrogenated Methyl Abiate, Polyaminopropyl Biguanide.

1 Certified by a USDA third party agency

Other Information

SPL UNCLASSIFIED SECTION

High sun protection product.

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-800-798-7970

PRINCIPAL DISPLAY PANEL - 100 ml Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn Out®

BROAD SPECTRUM
SPF 30

OCEAN TESTED
PHYSICAL
SUNSCREEN

No Nanoparticles
Petroleum-free, Paraben-free

Enriched with Antioxidants,
Organic Avocado Oil & Helionori

Water Resistant (40 min)

PRINCIPAL DISPLAY PANEL - 100 ml Tube Label
PRINCIPAL DISPLAY PANEL - 100 ml Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55777-0100-12022-01-28C16284748780-1d6a99b39-d36d-a426-e053-dadaa90af4c2Burn Out ® SPF-30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55777-0100-1Burn Out SPF-30 Sunscreen100 mL in 1 TUBELOTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55777-0100BURN OUT SPF-30 SUNSCREEN (ZINC OXIDE) LOTION [SUN RESEARCH LLC]3Legacy NDC, 1 package rows20200122_4de75ca6-050d-4ca1-b9af-841a0f9c35ee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
avocado oilINACTIVE INGREDIENT6VNO72PFC11
cannabis sativa seed oilINACTIVE INGREDIENT69VJ1LPN1S1
cetyl dimethicone 150INACTIVE INGREDIENT5L694Y0T221
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P1
green tea leafINACTIVE INGREDIENTW2ZU1RY8B01
hyaluronic acidINACTIVE INGREDIENTS270N0TRQY1
hydrogenated methyl abietateINACTIVE INGREDIENTA23O709X8O1
magnesium sulfateINACTIVE INGREDIENTDE08037SAB1
polihexanideINACTIVE INGREDIENT322U039GMF1
polyglyceryl-10 laurateINACTIVE INGREDIENTMPJ2Q8WI8G1
pomegranate juiceINACTIVE INGREDIENT99S671U9KB1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X1
tocopherolINACTIVE INGREDIENTR0ZB2556P81
tricaprylinINACTIVE INGREDIENT6P928589881
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55777-010055777-0100-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
water059QF0KO0RIACT
aloe vera leafZY81Z83H0XIACT
TRICAPRILIN6P92858988IACT
sorbitan monostearateNVZ4I0H58XIACT
polyglyceryl-10 laurateMPJ2Q8WI8GIACT
cetyl dimethicone 1505L694Y0T22IACT
magnesium sulfate, unspecified formDE08037SABIACT
avocado oil6VNO72PFC1IACT
cannabis sativa seed oil69VJ1LPN1SIACT
green tea leafW2ZU1RY8B0IACT
tocopherolR0ZB2556P8IACT
pomegranate juice99S671U9KBIACT
hyaluronic acidS270N0TRQYIACT
ethylhexylglycerin147D247K3PIACT
hydrogenated methyl abietateA23O709X8OIACT
polihexanide322U039GMFIACT

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 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii candidate
11 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / TOPICAL2.15 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABTABLET, FILM COATED / ORAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / ORAL62.5 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABCAPSULE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
tricaprylinTRICAPRILIN6P92858988INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL1 mgExact identifier — unii candidate
2 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSPRAY / TOPICAL4.58 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XLOTION / TOPICAL89 mgExact identifier — unii candidate
11 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSUPPOSITORY / VAGINALNAExact identifier — unii candidate
11 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
tocopherolTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
tricaprylinTRICAPRILIN6P92858988INJECTABLE, LIPOSOMAL / INFILTRATION0.2 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XSOLUTION / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XTABLET / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABTABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
magnesium sulfateMAGNESIUM SULFATEDE08037SABTABLET / ORAL2.9 mgExact identifier — unii candidate
6 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
c5557681-f4ae-461b-91d3-80f6c741dcac4de75ca6-050d-4ca1-b9af-841a0f9c35ee2020-01-21WarningsExact identifier
spl id: c5557681-f4ae-461b-91d3-80f6c741dcac
spl set id: 4de75ca6-050d-4ca1-b9af-841a0f9c35ee

Reported adverse events (FAERS/openFDA)#

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