FDA.reportPublic FDA data

Sunscreen ULTRA Broad Spectrum

Product NDC
49035-566
11-digit product format
490350566
Labeler code
49035
Product ID
49035-566_249e6f05-e357-d197-e063-6294a90a81e9
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone Homosalate Octisalate Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
WAL-MART STORES INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-21
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sunscreen ULTRA Broad Spectrum
Brand name suffix
Equate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE150 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
68524d2b-284c-4a69-9b0e-8d2ad80822e2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-566-11Sunscreen ULTRA Broad SpectrumEquate237 mL in 1 BOTTLELOTION2377
49035-566-14Sunscreen ULTRA Broad SpectrumEquate473 mL in 1 BOTTLELOTION4737
49035-566-49Sunscreen ULTRA Broad SpectrumEquate44.4 mL in 1 BOTTLELOTION44.47
49035-566-72Sunscreen ULTRA Broad SpectrumEquate946 mL in 1 BOTTLE, PUMPLOTION9467

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-566SUNSCREEN ULTRA BROAD SPECTRUM EQUATE (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [WAL-MART STORES INC.]7Current NDC, Legacy NDC, 4 package rows20241018_68524d2b-284c-4a69-9b0e-8d2ad80822e2.zip

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 46 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arizona Sun Kids Sunscreen SPF 30SUNSCREENArizona Sun Products10f60367-6681-a589-e063-6394a90a6bb82026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30SUNSCREENArizona Sun Products115b4d4c-51f1-ad62-e063-6294a90a3e532026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 30SUNSCREENArizona Sun Products10e48195-7bae-2422-e063-6394a90a261c2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 30SUNSCREENArizona Sun Products10e276e4-81f1-9429-e063-6394a90a800d2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 8SUNSCREENArizona Sun Products106a9608-f7a4-0f8c-e063-6394a90a26ab2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Bikerblok Lip Balm SPF 15LIP BALMArizona Sun Products11fced72-39f9-f3a3-e063-6294a90a8b732026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Golfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fc2a82-260c-7cd3-e063-6394a90af2c12026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd9aa5-dbd6-e5a7-e063-6394a90a3eac2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Golfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fc93a7-f5be-965d-e063-6394a90ab3352026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Bikerblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd1661-1b91-b65b-e063-6394a90af89b2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Lipkist Lip Balm SPF 15LIP BALMArizona Sun Products11fbcb81-2735-53c8-e063-6394a90ab0fa2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15LIP BALMArizona Sun Products11fd8776-99f8-e5a4-e063-6394a90a20332026-04-09WarningsExact identifier
application number: M020
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
application number: M020
Pro-Tect Sports Sunscreen SPF 20MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEABBE Laboratories, Inc.35869e8d-8e48-4b22-8af3-6964fe8ac1822026-04-09WarningsExact identifier
application number: M020
Sunright 50AVOBENZONE, HOMOSALATE, AND OCTINOXATENSE Products, Inc.b1b76481-da23-427f-9b34-b987019fa5322026-04-09WarningsExact identifier
application number: M020
ThinkBaby SPF 30ZINC OXIDEthinkOperations,LLC06862b00-c937-41af-ab5d-cea34160d0352026-04-09WarningsExact identifier
application number: M020
Nutricentials Day Dream ProtectiveHOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.4a376e93-85e8-40a5-8641-d3e3d11fdeea2026-04-08WarningsExact identifier
application number: M020
AGE20S UV MINERAL PRIMING SUNSCREENZINC OXIDEAekyung Industrial Co., Ltd.43c1f70b-0664-40be-e063-6394a90a2b482026-04-08WarningsExact identifier
application number: M020
AGE20S SUNSCREEN DUOZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAekyung Industrial Co., Ltd.4eef11cd-85a1-0e44-e063-6394a90a5d442026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-566-1149035056611237 mL in 1 BOTTLE (49035-566-11) 237 ml2020-10-060000-00-00NoNoCurrent
49035-566-1449035056614473 mL in 1 BOTTLE (49035-566-14) 473 ml2019-02-210000-00-00NoNoCurrent
49035-566-494903505664944.4 mL in 1 BOTTLE (49035-566-49) 44.4 ml2020-10-060000-00-00NoNoCurrent
49035-566-7249035056672946 mL in 1 BOTTLE, PUMP (49035-566-72) 946 ml2020-06-110000-00-00NoNoCurrent