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 187 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.5ff2b9e4-a778-4667-8c3c-3561317b374a2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.bc4f909f-3e2c-4fd7-a129-3c2fac8259f02025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.2dd9a30a-2cde-44c0-9350-3aeab9f7091b2025-09-12WarningsExact identifier
application number: M020
Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri TintZINC OXIDEDolce & Gabbana Beauty S.R.Le375412e-8685-49a2-b1b0-00ab114e14b72025-09-12WarningsExact identifier
application number: M020
Beach Club Mineral SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incd9aae241-229e-4123-abe9-99f74f5ab0b32025-09-12WarningsExact identifier
application number: M020
Resting Beach Face Broad Spectrum SPF 30 Sunscreen SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.3e8b0a0b-846a-cce7-e063-6294a90a6bb32025-09-11WarningsExact identifier
application number: M020
sunscreenTITANIUM DIOXIDE(NANO)Mingyu (guangdong) Cosmetics Technology Co., Ltd3e6fe9f3-486b-bba7-e063-6294a90adf372025-09-10WarningsExact identifier
application number: M020
Zinc Oxide Titanium OxideZINC OXIDE TITANIUM OXIDEHello Bello3e66c234-a152-098e-e063-6394a90ab5402025-09-10WarningsExact identifier
application number: M020
Basin Sun Stick SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3e78026e-0a6a-9e67-e063-6294a90a1bca2025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 30N Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.428dac83-37dc-4b54-82e9-664f59f9af332025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 31N Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.3174b962-12c0-43b4-8a9c-56fb044afd662025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 34W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.c4135505-f0c5-4a91-91e2-ca0e38a0136c2025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 35W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.c5f65d27-4ad8-4188-98aa-0d9c2dd361802025-09-10WarningsExact identifier
application number: M020
Zinc Oxide Titanium OxideZINC OXIDE TITANIUM OXIDEHello Bello3e89d30e-b6cd-fabe-e063-6294a90a30ff2025-09-10WarningsExact identifier
application number: M020
Ocean Potion Suncare 30 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e60bd44-1984-57c6-e063-6294a90a1f4e2025-09-09WarningsExact identifier
application number: M020
Ocean Potion Suncare 70 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e60d362-4700-1042-e063-6394a90ab39f2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 25W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.3d2a702b-2ff6-473a-9ab1-823e0e53a8cf2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 29W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.285c9b63-ae65-4508-8bba-1541b3cc43802025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 26C Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.733fbb38-1481-415c-8161-18816e87ee4b2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 28W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.42d51bd5-0678-4e30-80f7-db10281b95282025-09-09WarningsExact 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