FDA.reportPublic FDA data

BabyGanics Sunscreen

Product NDC
59062-1229
11-digit product format
590621229
Labeler code
59062
Product ID
59062-1229_288cb5ff-0e3f-40de-8e46-3424f6d03c2c
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTINOXATE, and OCTISALATE
Dosage form
SPRAY
Route
TOPICAL
Labeler
KAS Direct LLC dba BabyGanics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-21
Marketing end
2026-12-31
Substance
ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength
112; 50; 40 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 Sunscreen
Brand name suffix
30 SPF

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE112 mg/mL
OCTINOXATE50 mg/mL
OCTISALATE40 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
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59062-1229-12020-02-05C16284748780-19d75b9d0-6898-f424-e053-dadaa90a57cebabyganics® Sunscreen Spray 30 SPF
59062-1229-12020-01-31C16284748780-19d75b9d0-6898-f424-e053-dadaa90a57cebabyganics® Sunscreen Spray 30 SPF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-1229-1BabyGanics Sunscreen 30 SPF177 mL in 1 BOTTLE, DISPENSINGSPRAY1775

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
OCTISALATEACTIVE MOIETY4X49Y0596WBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERYL CAPRYLATEINACTIVE INGREDIENTTM2TZD4G4ABABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)INACTIVE INGREDIENTAG75W62QYUBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
POLYGLYCERYL-6 DIOLEATEINACTIVE INGREDIENT062SZD3F3XBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
SODIUM MAGNESIUM FLUOROSILICATEINACTIVE INGREDIENTU1QJ22MC8EBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
SQUALANEINACTIVE INGREDIENTGW89575KF9BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
WATERINACTIVE INGREDIENT059QF0KO0RBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1229BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]5Current NDC, Legacy NDC, 1 package rows20241225_391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1.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 148 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb14c4f-a435-aa6e-e063-6394a90a7d8d2025-12-08WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 40 Non-TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc4f701-eea2-7913-e063-6294a90a86932025-12-08WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc55e8c-41d6-15cc-e063-6394a90ac5432025-12-08WarningsExact identifier
application number: M020
Zinc Oxide SPF 40 TintedZINC OXIDESkin Restoration Aesthetics2fc60a39-789b-3d11-e063-6294a90a9abf2025-12-08WarningsExact identifier
application number: M020
Zinc Oxide SPF 40 Non-TintedZINC OXIDESkin Restoration Aesthetics2fc68041-acfe-8db6-e063-6294a90ad8ba2025-12-08WarningsExact identifier
application number: M020
Daily Tinted Mineral SPFTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc6e168-b2c1-bf9d-e063-6394a90aade72025-12-08WarningsExact identifier
application number: M020
Ultra Solar Shield non-tinted moisturizing mineral SPF 40ZINC OXIDEJoyce Kelly Enterprises365bdf7a-c034-beef-e063-6394a90a4dd72025-12-08Exact identifier
application number: M020
UV Shade tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b3a1e-8410-da06-e063-6294a90a462f2025-12-08Exact identifier
application number: M020
Solar Shield non-tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b68a0-0f89-0f43-e063-6294a90a5eee2025-12-08Exact identifier
application number: M020
Ultra UV Shade tinted moisturizing mineral SPF 40ZINC OXIDEJoyce Kelly Enterprises365ba78a-b7df-a31f-e063-6394a90a16732025-12-08Exact identifier
application number: M020
Mineral Sunscreen tintedTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3000a0a7-2b51-b832-e063-6294a90a4a082025-12-08WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001028b-bb36-04ec-e063-6294a90a1e492025-12-08WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001aa3a-cc8b-6ad4-e063-6394a90a223f2025-12-08WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC300268ff-f9ef-1006-e063-6294a90a5fdf2025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF 40 Lightly TintedZINC OXIDEFace 5, LLC3001ef4f-4cbb-8931-e063-6394a90a5cef2025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF40 Non-TintedZINC OXIDEFace 5, LLC300218c9-65cf-d984-e063-6294a90a15172025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF 40 Lightly TintedZINC OXIDEFace 5, LLC300303e7-ef89-7449-e063-6294a90ac8112025-12-08WarningsExact identifier
application number: M020
Clear Path Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDELULUS SPA BOUTIQUE37657755-fa82-88a0-e063-6394a90ade472025-12-08Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare376468ce-8d9b-b672-e063-6294a90a0bd12025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-1229-159062122901177 mL in 1 BOTTLE, DISPENSING (59062-1229-1) 177 ml2013-06-212026-12-31NoNoCurrent