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 82 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d6e04a-fa30-ba48-e063-6394a90a1bbf2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f780daa-4c91-5a68-e063-6394a90afd412026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50ZINC OXIDECrown Laboratories99839894-9695-2cd1-e053-2995a90acba62026-01-12WarningsExact identifier
application number: M020
Blue Lizard SPF 15 Lip BalmZINC OXIDECrown Laboratories1bf8fb7e-9d5b-86d4-e063-6294a90afddc2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50ZINC OXIDECrown Laboratories9983563c-1e63-0748-e053-2a95a90a971e2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Baby SPF 50ZINC OXIDECrown Laboratories9948f5b8-43bd-1c99-e053-2a95a90a61212026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer SPF 50 SunscreenZINC OXIDECrown Laboratories3368f1cb-c341-e886-e063-6394a90a9b7c2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f3844d8-0367-aad9-e063-6294a90a1fce2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories30cd79da-2f25-a42a-e063-6394a90a83322026-01-12WarningsExact identifier
application number: M020
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREENTITAMIUN DIOXIDE, ZINC OXIDEUCL Co., Ltd.4837b4f6-ada9-801a-e063-6294a90a85472026-01-12WarningsExact identifier
application number: M020
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
application number: M020
GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASEHOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.48393640-4b97-04de-e063-6294a90aa6a62026-01-12WarningsExact identifier
application number: M020
Hale and Hush Broad Spectrum SPF 30 SPF 30ZINC OXIDEEclectic Solutions LLC0530904f-b02c-d8cf-e063-6294a90aa5a72026-01-12WarningsExact identifier
application number: M020
Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEMinori Inc.1d4e2654-1638-0d01-e063-6394a90af3032026-01-12WarningsExact identifier
application number: M020
LUXURY BODY RITUAL HYDRATING SPF 30ZINC OXIDEJANE STREET LLC15e9d688-f226-1a19-e063-6394a90ab9062026-01-12WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD0426b1e9-063b-c1e6-e063-6294a90a25542026-01-11WarningsExact identifier
application number: M020
SPF30 MINERAL SUNSCREEN MOUSSEZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48031a0f-c2ed-5424-e063-6294a90ad0ff2026-01-10WarningsExact identifier
application number: M020
SPF 30 MINERAL WHIPPED CREAMS SHIMMERZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48037a05-722e-4231-e063-6294a90ac51f2026-01-10WarningsExact identifier
application number: M020
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFUTURE 8 LLC9922f132-f6a5-41ca-847a-936b20bf17162026-01-09WarningsExact 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