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 167 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well People Bio Tint SPF 30 Sunscreen 8NZINC OXIDEe.l.f. Cosmetics, Incc8aa662c-0f06-712b-e053-2995a90aae0b2025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen AFTERGLOWZINC OXIDEe.l.f. Cosmetics, Incc8aa9325-4fad-ddf9-e053-2a95a90a66392025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 9wZINC OXIDEe.l.f. Cosmetics, Incc8a92c58-d981-0948-e053-2a95a90a16f82025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen WINEZINC OXIDEe.l.f. Cosmetics, Incc8aa873e-8271-8cf0-e053-2995a90a3cec2025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen NATURALZINC OXIDEe.l.f. Cosmetics, Incc8aa7ae9-7d03-db7d-e053-2995a90ae72b2025-11-07WarningsExact identifier
application number: M020
Neutrogena Clear Face Serum Fragrance Free SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeb705402-f8cb-5079-e053-2a95a90a405c2025-11-06WarningsExact identifier
application number: M020
Neutrogena Cool Dry Sport Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC5c1a0437-c269-4cd3-b91a-e2de799b853e2025-11-06WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC10ca67ca-c372-44a9-8933-84cce9fb99342025-11-06WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0464448b-342b-4e54-a20e-6ec6bd6228892025-11-06WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC7f60d6bd-1735-4390-bc8a-e3876ab7ad502025-11-06WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer with Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCea876490-979b-401c-a6bf-35649e7deda02025-11-06WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCcdbe250b-2b64-78fd-e053-2995a90a6c332025-11-06WarningsExact identifier
application number: M020
Aveeno FavoritesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCf3c925cc-7993-70bb-e053-2a95a90abdde2025-11-06WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC2510d9fe-2aa7-44ee-9525-ad5163dfee942025-11-06WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC39710a1a-fe8c-41f2-b60c-db3e99d60a862025-11-06WarningsExact identifier
application number: M020
Neutrogena Boost Your Skins Vitals Team RegenerateAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0acd9110-4ba5-227a-e063-6294a90ad9422025-11-06WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free Oil Free Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC3e25a4ce-dbdd-4830-a3d8-a2dfb3bcb0782025-11-06WarningsExact identifier
application number: M020
Neutrogena Oil Free Moisture Broad Spectrum SPF15AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC18303bc2-2e00-4a9e-900f-86397ca9d1632025-11-06WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Fragrance Free SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeb7022e7-0929-fdb4-e053-2995a90a9e6c2025-11-06WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 55 ClubtrayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0bd538e9-7716-9bc2-e063-6294a90a9a072025-11-06WarningsExact 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