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 180 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premium Moisturizing Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4346f7a-3642-05d8-e053-2a95a90a013d2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4206dad-6a17-2f56-e053-2a95a90a69dc2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf434089c-126f-441c-e053-2995a90ab0c72025-10-09WarningsExact identifier
application number: M020
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)ZINC OXIDENapoleon PerdisCosmetic Pty Ltdbe64bb40-b1a9-2308-e053-2a95a90a69c82025-10-09WarningsExact identifier
application number: M020
Organys Open Formula SheerZINC OXIDEOrganys Beauty0b3ab551-cb66-cf86-e063-6394a90a7ab42025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
application number: M020
Organys Derma Made SheerZINC OXIDEOrganys Beauty0b39f550-bd34-509d-e063-6294a90a51d02025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty0b37a73b-73ca-501f-e063-6294a90a62912025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09b8b8c0-4066-9cbe-e063-6394a90aca242025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 3)ZINC OXIDEResette, Incdc89ab76-da32-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 4)ZINC OXIDEResette, Incdc89ab0b-d53e-983f-e053-2a95a90a127f2025-10-09WarningsExact identifier
application number: M020
Petroleum-Free Lip BalmOCTINOXATE AND OXYBENZONEMedline Industries, LP6125d98a-6fc7-4f50-924e-3b1f7ee951f42025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 1)ZINC OXIDEResette, Incdc89429a-022c-dd10-e053-2a95a90ac26a2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 2)ZINC OXIDEResette, Incdc89ab76-da2f-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Dr Lift SPF 50 Clear StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESpa de Soleil40c11b19-fc91-2033-e063-6394a90a5a5f2025-10-09WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Mineral BabyZINC OXIDEBlack Girl Sunscreen302bccc6-7bf3-cc69-e063-6294a90a625c2025-10-09WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0436b-85b6-5099-e063-6294a90a4c2e2025-10-09WarningsExact identifier
application number: M020
CoreTex Professional Outdoor Skin Protection WalletCORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLETCoreTex Products Incf57bc089-405b-cdcd-e053-2995a90a9d122025-10-09WarningsExact identifier
application number: M020
Mist Me SPF-40ZINC OXIDECove Suncare LLCb7f09089-54a4-4f60-b632-e3f4321313ec2025-10-09WarningsExact 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