FDA.reportPublic FDA data

SPF 50 plus Sunscreen

Product NDC
59062-1000
11-digit product format
590621000
Labeler code
59062
Product ID
59062-1000_a7636b53-d9d4-4c4f-929a-515a8cc78659
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, OCTISALATE, and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
KAS Direct LLC dba BabyGanics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-24
Marketing end
2026-12-31
Substance
TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE
Active strength
30; 50; 60 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59062-100059062-1000-1DDiscontinued by firm2026-10-23
excluded packagepackage59062-100059062-1000-2DDiscontinued by firm2026-10-23
excluded packagepackage59062-100059062-1000-6DDiscontinued by firm2026-10-23

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
SPF 50 plus Sunscreen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE30 mg/mL
OCTISALATE50 mg/mL
ZINC OXIDE60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-1000-1SPF 50 plus Sunscreen354 mL in 1 TUBELOTION3542
59062-1000-2SPF 50 plus Sunscreen59 mL in 1 TUBELOTION592
59062-1000-2outdoor explorer set59 mL in 1 TUBELOTION59 mL50 mg in 1mL2
59062-1000-6SPF 50 plus Sunscreen177 mL in 1 TUBELOTION1772
59062-1000-8SPF 50 plus Sunscreen236 mL in 1 TUBELOTION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1000OUTDOOR EXPLORER SET (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20210720_726096c2-514a-439a-9697-346ca684c493.zip
59062-1000SPF 50 PLUS SUNSCREEN (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC, 4 package rows20241220_5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b.zip
59062-1000SUNCARE ESSENTIALS (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20250104_96fd2cf8-cb07-4ec1-8946-8e862f6d8377.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 140 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e4fa-883b-fb9c-e063-6394a90adcc42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483dd31-417b-01ba-e063-6294a90a83a82025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e998-6122-fb84-e063-6394a90a159f2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c96e691a-99e1-4cb4-aebf-7444f4a6865f2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ab1c8e9e-fd8f-473e-8930-625706e8e9d62025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.17073264-ec02-4801-841d-86778debd8c42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.caee5c88-1907-41c1-987e-5bc544267dca2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.973b70f1-ee59-4dd9-aca3-432d721204ab2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.208fe03e-384b-4599-a4d0-a553fba306da2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.279258dd-b3fa-47be-8540-66bd9c879fc52025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.4206b607-5c26-4c9d-ade7-58c9740cdbe82025-12-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beauty949a2796-717c-4820-ae09-2636e3dd6e3d2025-12-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium DarkOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyf9bbc6d3-eb50-4953-8dba-732094b4c7c42025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD53df3126-1136-490a-b339-5876ce89499e2025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 50 kidsHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD3fa04557-2bc1-4eb4-aed8-eacc791896132025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 40OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENIDARIA TECHNOLOGY LTDc900b88b-1de1-4df9-af84-d9001e1d47642025-12-09WarningsExact identifier
application number: M020
StriVectin ANTI-WRINKLE GLOWFECTOR SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.ed357e76-54a1-66bd-e053-2a95a90a1e2a2025-12-09WarningsExact identifier
application number: M020
Non-tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dd2f6b-5dcc-b081-e063-6394a90ae5f12025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dc6e23-ecca-ed0b-e063-6294a90a79512025-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-1000-159062100001354 mL in 1 TUBE (59062-1000-1) 354 ml2017-07-240000-00-00NoNoCurrent
59062-1000-25906210000259 mL in 1 TUBE (59062-1000-2) 59 ml2017-07-240000-00-00NoNoCurrent
59062-1000-659062100006177 mL in 1 TUBE (59062-1000-6) 177 ml2017-07-240000-00-00NoNoCurrent
59062-1000-859062100008236 mL in 1 TUBE (59062-1000-8) 236 ml2017-07-242026-12-31NoNoCurrent