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 76 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior824c5f13-970e-4e9e-8f2a-2a01973d2e592026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7621ef5-47fc-4ccc-aedd-eac328ace7b92026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64a29ff8-e24d-4818-9b54-734a0eb2a13f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17a0201b-b797-4e65-838f-1ce8d408a0202026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72e2c71a-da1d-497f-a8b7-491cff951c632026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior19d1432a-96b0-4cef-b13e-895dd41b41d62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a06c820-ccd8-47ce-8bbf-7e90da92b1de2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior205e195a-fd30-44f7-9294-e701f0f766d62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5495ff75-0c83-4491-8af7-4aed7a779d7f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior10bc345d-a5b1-4b70-bfa6-a2d7816904bf2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30268b6e-d42a-4314-b82f-24f9e81cca2a2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior545c962f-2a59-4d94-8fef-ebdba4127f422026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17c9226b-459c-42fe-ac50-7e26db6b49af2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbf323e10-5479-44b3-b4b9-b8ca6b0f76882026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d6a5133-b847-4ecf-8c33-1cb05aca6b912026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior275be888-2c52-43ed-846a-55525002edcd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc73576a6-dbab-4205-add5-876a060b50222026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ae761ac-df06-4913-a8bf-8ca1be32b5b72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72c45120-6997-4250-b9b4-1cdb762efe1a2026-01-16WarningsExact 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