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 30 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SP-FFC3-L0TN Barrier Protection Hydrating Mineral Face SunscreenBARRIER PROTECTION HYDRATING MINERAL FACE SUNSCREENEpic Etailers, LLC (DBA: Beauty by Earth)5078479e-a196-7e4d-e063-6394a90ab2662026-05-19WarningsExact identifier
application number: M020
InvisibleMatteBarrierDefenseCeramideSunscreenSerumSPF30SP-FSRM-N0TTINVISIBLE MATTE BARRIER DEFENSE CERAMIDE SUNSCREEN SERUM SPF 30Epic Etailers, LLC (DBA: Beauty by Earth)50790945-f359-07c8-e063-6294a90a5af92026-05-19WarningsExact identifier
application number: M020
Sun Bum Amazon 8 OZ SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum522fc8a4-ce9f-8be8-e063-6294a90aebf02026-05-19WarningsExact identifier
application number: M020
Timesavvy Hybrid Sheer Sun Serum Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEPROBETTER USA INC.66624df4-cb6c-4cfb-bbbe-9f885f2ad7782026-05-18WarningsExact identifier
application number: M020
Hampton Sun SPF 50AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 %S&C Hampton Sun LLC4df050f9-1185-4ee4-a0cd-84ba9d254e582026-05-18Exact identifier
application number: M020
Hampton Sun SPF 70 KidsAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLC7c976082-3265-4c0b-9985-277d279888952026-05-18WarningsExact identifier
application number: M020
Evereden Kids Cooling Mineral Sunstick SPF30ZINC OXIDEEden Brands Inc.521afa81-737f-81d4-e063-6394a90ad3072026-05-18WarningsExact identifier
application number: M020
cle de peau BEAUTE RESTORATIVE DAY SUPREMEAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporation157e52c5-f6fa-430b-bbb8-86b7c0868ad32026-05-18WarningsExact identifier
application number: M020
cle de peau BEAUTE SKIN BEAUTY ENHANCERAVOBENZONE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationbc6230f1-dba2-4418-b48c-c5e67aebd1bd2026-05-18WarningsExact identifier
application number: M020
Hampton Sun SPF 30 SILK BODYAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLCed0c184d-473a-4c4c-b6ec-e1d79ad584602026-05-18WarningsExact identifier
application number: M020
Sheer Defense Tinted SPF 46ZINC OXIDE, OCTINOXATEPrivate Label Skin Care017265e9-31e6-43ce-9432-cb88f471c4962026-05-18WarningsExact identifier
application number: M020
Aveeno Daily Moisturizing Face Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC51d59378-df72-e438-e063-6294a90a97f12026-05-15WarningsExact identifier
application number: M020
Natural Sense SPF 50 SunscreenSUNSCREENDr. Natural LLC49a2430e-c15b-4610-e063-6294a90ac5202026-05-15WarningsExact identifier
application number: M020
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc.23cc5ff4-f842-4e3e-ac5c-23dbaf7d39142026-05-15WarningsExact identifier
application number: M020
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDESICOS ET CIEc688f8e6-2cd2-40db-b03f-90fd74c2d89c2026-05-15WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
application number: M020
Target Up and Up Ultra Light Dry-Touch SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51de3d0b-2721-92d3-e063-6394a90a18bb2026-05-15WarningsExact identifier
application number: M020
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 8 Bronze SunscreenHOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%S&C Hampton Sun LLC7cf4d943-be6e-4e38-8891-1e0b22af55362026-05-14WarningsExact 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