FDA.reportPublic FDA data

SPF 50 plus Sunscreen

Product NDC
59062-1200
11-digit product format
590621200
Labeler code
59062
Product ID
59062-1200_d1f4c797-2359-448a-8112-f69f227f475d
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
KAS Direct LLC dba BabyGanics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-21
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
79; 67 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
SPF 50 plus Sunscreen
Brand name suffix
All Mineral Active Ingredients
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE79 mg/g
ZINC OXIDE67 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal 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
247aae3d-1845-4dd8-b774-b9e8214809a2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-1200-1SPF 50 plus Sunscreen All Mineral Active Ingredients13 g in 1 APPLICATORSTICK133
59062-1200-1SPF 50 plus Sunscreen All Mineral Active Ingredients1 in 1 BLISTER PACKSTICK13
59062-1200-2SPF 50 plus Sunscreen All Mineral Active Ingredients2 in 1 BLISTER PACKSTICK23
59062-1200-2SPF 50 plus Sunscreen All Mineral Active Ingredients13 g in 1 APPLICATORSTICK133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1200SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS (TITANIUM DIOXIDE AND ZINC OXIDE) STICK KIDS SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [KAS DIRECT LLC DBA BABYGANICS]3Current NDC, Legacy NDC, 4 package rows20241222_247aae3d-1845-4dd8-b774-b9e8214809a2.zip
59062-1200SUNCARE 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 32 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frase Skin SPF 30 Face Sunscreen Activated Vitamin D TechnologyAVOBENZONE, OCTISALATE, OCTOCRYLENEFrase Skin PTY LTDd904fd23-a3a1-4564-8eec-13a4c96e23f72026-05-12WarningsExact identifier
application number: M020
Hawaii Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC24678326-547f-427d-a481-d8c40380e30a2026-05-12WarningsExact identifier
application number: M020
Caribbean Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC20aadcf6-16a3-4344-837b-b91ba8753fb02026-05-12WarningsExact identifier
application number: M020
Cancer Council Daily Face Moisturizer SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1b4333b8-5747-c591-e063-6294a90a99242026-05-12WarningsExact identifier
application number: M020
Lather Daily Defense Mineral SPF 45 Facial SunscreenZINC OXIDELather, Inc.50c732a0-b282-d61b-e063-6294a90aa76b2026-05-12WarningsExact identifier
application number: M020
Hampton Sun SPF50 Mineral Face SunscreenHOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%S&C Hampton Sun LLCf1c5310b-c43b-475d-8a50-d55759ad31642026-05-12WarningsExact identifier
application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
application number: M020
Stellar Mineral Glow Guard Sunscreen Broad Spectrum SPF 50ZINC OXIDEStellar Beauty Co.0f7ee8c6-3af2-42a2-b341-3e0da42c7c932026-05-11WarningsExact identifier
application number: M020
Frase Skin SPF 50 Activated Vitamin D Technology CoolAVOBENZONE, OCTISALATE, OCTOCRYLENEFrase Skin PTY LTD0a5cc927-0fd3-4c8f-b847-a274f6eb09fb2026-05-11WarningsExact identifier
application number: M020
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral SunscreenZINC OXIDEMiami Beach Bum3b778530-9af0-48eb-bd91-d9ac99f2983f2026-05-11WarningsExact identifier
application number: M020
Walgreens SPF 60 Melt-in Milk SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalgreens345955ea-f37a-8629-e063-6294a90aa7cc2026-05-11WarningsExact identifier
application number: M020
DERMATONE SPF50 SunscreenAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Dermatone Labs LLC4dc81593-4790-403f-9d49-6569bcd0fea22026-05-11WarningsExact identifier
application number: M020
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
application number: M020
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
application number: M020
ChapStick Moisturizer Original SPF 15SPF 15 SKIN PROTECTANTSuave Brands Co., LLC47bfa8ea-4d8d-cd13-e063-6394a90a71aa2026-05-11WarningsExact identifier
application number: M020
EELHOE SunscreenTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5196ccb0-4515-7e40-e063-6394a90a09bd2026-05-11WarningsExact identifier
application number: M020
Mediheal Madecassoside Moisture Sun SerumHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE7400547c66535-8287-9b74-e063-6394a90ac3b62026-05-10WarningsExact identifier
application number: M020
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLCaf56f16a-2643-4bfc-9e05-dfba79cdab8a2026-05-08WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Cool GlowZINC OXIDEIris and Romeo514f7d70-7b8b-0992-e063-6394a90a1e982026-05-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-1200-1590621200011 APPLICATOR in 1 BLISTER PACK (59062-1200-1) / 13 g in 1 APPLICATOR1 applicator2013-06-210000-00-00NoNoCurrent
59062-1200-2590621200022 APPLICATOR in 1 BLISTER PACK (59062-1200-2) / 13 g in 1 APPLICATOR2 applicator2013-06-210000-00-00NoNoCurrent