FDA.reportPublic FDA data

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 217 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEKOS America, Inc.2b41c17d-1394-0c2f-e063-6394a90a0c492025-04-15WarningsExact identifier
application number: M020
Urban Antioxidant Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMDr. Loretta, LLC930150a3-08bb-17fd-e053-2995a90a786b2025-04-15WarningsExact identifier
application number: M020
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
application number: M020
Dr.Ceuracle HYDRA BARRIER SUNSCREENZINC OXIDELeegeehaam Cosmetics22c05215-4983-b32e-e063-6394a90a9f672025-04-13WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3285e28d-5716-b576-e063-6294a90a89052025-04-11WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Fragrance Free Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32876315-f81f-fdd2-e063-6394a90ad5f72025-04-11WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3287ae2e-759e-31c5-e063-6394a90a892f2025-04-11WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32b5a19e-86d4-5ee1-e063-6394a90a12e22025-04-11WarningsExact identifier
application number: M020
LERINN ZINCPURE SUNMILK SPF 50ZINC OXIDESerrina Lin Skincare Inc32717b49-729c-a229-e063-6394a90a18fb2025-04-10WarningsExact identifier
application number: M020
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
application number: M020
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTOCRYLENE, ZINC OXIDE, OCTISALATESunstation USA LLC6007c125-f28a-45e5-b8f1-490ee04b78112025-04-09WarningsExact identifier
application number: M020
Pacifica Sun Dreams Illuminating SPF FoamHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPacifica Beauty, LLC2e0cb105-75c3-8032-e063-6394a90ab5022025-04-09WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANELG H&H CO., LTD.284cadf1-deb9-4f3d-e063-6394a90ab1222025-04-09WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDaa79b1a4-6b33-47c9-b55e-b813d9b222652025-04-09WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc OnlyZINC OXIDESPF Ventures, LLC3240cbe5-bfc8-17f7-e063-6394a90a1b982025-04-08WarningsExact identifier
application number: M020
ISA KNOX UV SUN PRO 365 Sheer Mineral FaceZINC OXIDELG HOUSEHOLD & HEALTH CARE LTD.2eeac795-b74e-b3a3-e063-6294a90abf522025-04-08WarningsExact identifier
application number: M020
The Face Shop Hydro Sun Barrier 2-in-1 SPF and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2ee9f271-b508-2304-e063-6294a90a37522025-04-08WarningsExact 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