Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50

Product NDC
53208-800
11-digit product format
532080800
Labeler code
53208
Product ID
53208-800_2c6c3748-418a-33ac-e063-6294a90adbca
Type
HUMAN OTC DRUG
Nonproprietary name
Ensulizole, Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
LG H&H Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-27
Substance
TITANIUM DIOXIDE; ENSULIZOLE; OCTINOXATE; ZINC OXIDE; OCTISALATE
Active strength
2.285; 1.75; 3.5; 5.825; 2.25 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53208-800-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53208-800-010efc9e666f02…f202fb6c5f17…

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
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE2.285 g/50mL
ENSULIZOLE1.75 g/50mL
OCTINOXATE3.5 g/50mL
ZINC OXIDE5.825 g/50mL
OCTISALATE2.25 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
9YQ9DI1W42Internal UNII lookup
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal 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
a4364c8d-8b74-130e-e053-2995a90ad1c1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-800-01Babience KIDS Sunscreen pinkfong BABY SHARK SPF 502 in 1 BOXLOTION23
53208-800-01Babience KIDS Sunscreen pinkfong BABY SHARK SPF 5050 mL in 1 TUBELOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-800BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50 (ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LG H&H CO., LTD.]3Current NDC, Legacy NDC, 2 package rows20250125_a4364c8d-8b74-130e-e053-2995a90ad1c1.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 18 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc511f6de9-264a-4cf2-97c3-aa8adbc52a872026-06-23WarningsExact identifier
application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 SunscreenZINC OXIDETHE AVON COMPANY54f1b153-c79b-bcf8-e063-6394a90ae4262026-06-23WarningsExact identifier
application number: M020
CVS 70 Daily Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY54f25934-b4c4-4fc8-e063-6294a90a543a2026-06-23WarningsExact identifier
application number: M020
Soleil Set sunscreen SPF 50AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%The Soleil Groupcc4e4b99-5f42-4a93-a3a0-ea19f57d27832026-06-23WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY54f6d7c1-59d1-0b36-e063-6394a90a17a32026-06-23WarningsExact identifier
application number: M020
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
application number: M020
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
application number: M020
Mama and Hapa s - Bulk Sunscreen Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED54e18569-2e51-366a-e063-6394a90af8ec2026-06-22WarningsExact identifier
application number: M020
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
application number: M020
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE COCO LOCOBy the Beach Suncare LLC549be1ca-df21-a643-e063-6394a90ac0262026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL COCO LOCOBy the Beach Suncare LLC549bad35-3005-875b-e063-6394a90ad31e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL MELON DAZEBy the Beach Suncare LLC549bbd19-8e22-e420-e063-6294a90a6a982026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CANDY CLOUDSBy the Beach Suncare LLC549bd1b1-a6e2-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CITRUS CRUSHBy the Beach Suncare LLC549bd1b1-a6ee-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENSummer Soles, LLC dba Farm House Freash Goods5488fd8c-7ef2-22c2-e063-6394a90aff3c2026-06-18WarningsExact identifier
application number: M020
Stream2Sea Sport Lip Balm SPF 50ZINC OXIDEStream2Sea, LLC5489fea5-bc0e-82cf-e063-6294a90aa0972026-06-18WarningsExact identifier
application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC4a6f9be3-2a56-8b41-e063-6294a90a30f82026-06-18WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50MINERAL SUNSCREENALAINA HEALTHCARE PRIVATE LIMITED7e036f9f-b26d-4f11-911c-c1fa854edb0f2026-06-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53208-800-01532080800012 TUBE in 1 BOX (53208-800-01) / 50 mL in 1 TUBE2 tube2020-04-270000-00-00NoNoCurrent