FDA.reportPublic FDA data

BABYGANICS SPF 50 Plus SUNSCREEN

Product NDC
59062-0120
11-digit product format
590620120
Labeler code
59062
Product ID
59062-0120_0bd9880a-6b33-495b-a58e-7a5e65cbac4a
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTISALATE, and OCTOCRYLENE
Dosage form
SPRAY
Route
TOPICAL
Labeler
KAS Direct LLC dba Babyganics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
Marketing end
2026-12-31
Substance
ZINC OXIDE; OCTISALATE; OCTOCRYLENE
Active strength
112; 50; 60 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
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
BABYGANICS SPF 50 Plus SUNSCREEN

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE112 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal 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
4075f9dc-c25f-434f-a3fc-a7f896295c3dAvailable 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
59062-0120-1BABYGANICS SPF 50 Plus SUNSCREEN177 mL in 1 BOTTLE, DISPENSINGSPRAY1774
59062-0120-6outdoor essentials177 mL in 1 BOTTLE, SPRAYSPRAY177 mL112 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-0120BABYGANICS SPF 50 PLUS SUNSCREEN (ZINC OXIDE, OCTISALATE, AND OCTOCRYLENE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]4Current NDC, Legacy NDC, 1 package rows20241225_4075f9dc-c25f-434f-a3fc-a7f896295c3d.zip
59062-0120OUTDOOR ESSENTIALS (ZINC OXIDE, OCTOCRYLENE, AND OCTISALATE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20211023_93ef5b1b-e4f4-4c86-a395-c19861866c3e.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 6 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
application number: M020
Meraki Protective Mist SunscreenBROAD SPECTRUM SPF 30MERAKI MEDICAL SPA LLC59446224-0e97-ae2c-e063-6394a90a2a652026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsExact identifier
application number: M020
Sun Zapper - Anti-ageing pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3f1dc3b2-c289-5996-e063-6394a90ac6222026-08-16WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d3d390-8b88-a6fe-e063-6394a90a9bf82026-08-12WarningsExact identifier
application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d7a3e3-b7df-43ce-e063-6294a90a729c2026-08-12WarningsExact identifier
application number: M020
HEB 50 Marigold Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.58dafa24-24d5-aeb4-e063-6394a90a3c252026-08-12WarningsExact identifier
application number: M020
TESALOVA Coconut SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONETesalova Viktoriia PMU LLC58dbb9f1-cfb3-62ac-e063-6394a90a61062026-08-12WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsExact identifier
application number: M020
Basin Coconut SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e93a6-dcf9-3687-e063-6394a90a73ac2026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-12WarningsExact identifier
application number: M020
doTERRA Sun BodyMINERAL SUNSCREENdoTERRA International, LLC58dcc56f-f093-469c-e063-6394a90a60882026-08-12WarningsExact identifier
application number: M020
Sonage Protec Plus SPF 30 Mineral SunscreenZINC OXIDEASA Universal Inc. dba: Sonaged92fc1df-bbeb-592a-e053-2a95a90a69512026-08-12WarningsExact identifier
application number: M020
Colorescience Total Protection Body Shield GlowZINC OXIDEColorescience52e1d987-a4f8-195e-e063-6294a90a56292026-08-11WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
application number: M020
Ciele Tint and ProtectZINC OXIDECiele0162d9c9-07fa-9210-e063-6294a90aa6872026-08-11WarningsExact identifier
application number: M020
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-08-10WarningsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-0120-159062012001177 mL in 1 BOTTLE, DISPENSING (59062-0120-1) 177 ml2019-07-012026-12-31NoNoCurrent
59062-0120-659062012006177 mL in 1 BOTTLE, SPRAY177 mlHistorical