FDA.reportPublic FDA data

SURFERS BARRIER SPF 50

Product NDC
58518-021
11-digit product format
585180021
Labeler code
58518
Product ID
58518-021_4953db07-e703-5cf0-e063-6394a90a1cad
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, TITANIUM DIOXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
Avasol LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-02
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
24.5; 6 g/100g; g/100g
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
SURFERS BARRIER SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE24.5 g/100g
TITANIUM DIOXIDE6 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec55eef0-17e6-416d-bd5e-548f2f323ceaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58518-021-012023-04-14C16284748780-1f386c64a-2ea9-0266-e053-dadaa90a7c1aSURFERS BARRIER SPF 50
58518-021-012023-01-30C16284748780-1f386c64a-2ea9-0266-e053-dadaa90a7c1aSURFERS BARRIER SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58518-021-01SURFERS BARRIER SPF 5028 g in 1 TUBESTICK285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58518-021SURFERS BARRIER SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) STICK [AVASOL LLC]4Current NDC, Legacy NDC, 1 package rows20241004_ec55eef0-17e6-416d-bd5e-548f2f323cea.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 146 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD46641a33-d658-4ef0-9b7a-062adc401dde2025-12-08WarningsExact identifier
application number: M020
Skin Filter Glow SPFZINC OXIDEMALORIE MILES36485f44-a6bd-9529-e063-6294a90af7a42025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES36499be5-d680-92bf-e063-6394a90a89db2025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES364ae392-480a-14ea-e063-6394a90a38832025-12-08Exact identifier
application number: M020
Personalized Moisturizer SPF 30ZINC OXIDE 10.00%Proven Skincared3cf8f81-d6ae-4570-ad86-43415e973e132025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2f9d087c-b2b3-5654-e063-6294a90a94e52025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faee7ef-fc0c-6d01-e063-6294a90a6d682025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faf530d-5574-b702-e063-6294a90ad6fd2025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2fb00db0-4c37-56c6-e063-6294a90a8aff2025-12-08WarningsExact identifier
application number: M020
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334afdc8-1e12-d787-e063-6294a90aed7c2025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334bf8ea-2485-84e8-e063-6294a90aefa62025-12-08Exact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334d694a-f9e4-ae86-e063-6394a90abfe12025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334e32a4-c3a5-e37d-e063-6294a90ad6cf2025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
application number: M020
Mineral Based Facial SunscreenZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3e8981ed-5847-7009-e063-6394a90a49a12025-12-08WarningsExact identifier
application number: M020
Replenishing Daily Protection Sunscreen InvisibleZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32462e88-0e74-a675-e063-6294a90ac5642025-12-08Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58518-021-015851800210128 g in 1 TUBE (58518-021-01) 28 g2020-01-020000-00-00NoNoCurrent