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 174 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KidsBliss Baby and Kids Mineral Sunscreen SPF50ZINC OXIDEVeganicSKN2dfa236f-128b-17bb-e063-6294a90aa29c2025-10-24WarningsExact identifier
application number: M020
Oze Sun Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd7477-445f-d1d5-e063-6394a90a46072025-10-24WarningsExact identifier
application number: M020
Oze Sun reef safe Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd936b-0ea6-03a2-e063-6394a90a4fba2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 yearsZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de1cd7-fdfd-7f7a-e063-6394a90a9b5c2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 7 years to adultZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de09dc-544f-9780-e063-6394a90acd272025-10-24WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC23670a30-6619-0651-e063-6394a90af9782025-10-24WarningsExact identifier
application number: M020
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30TITANIUM DIOXIDETHG Beauty USA LLC397b4338-fec8-5228-e063-6394a90ad97d2025-10-23WarningsExact identifier
application number: M020
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDETHG Beauty USA LLC38c80373-1d5a-c7f4-e063-6294a90aa9c22025-10-23WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35ZINC OXIDE, TITANIUM DIOXIDETHG Beauty USA LLC254b4692-a459-6119-e063-6394a90a0a602025-10-23WarningsExact identifier
application number: M020
AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENECHOP SAVER FRESH CITRUS SPF 15 LIP BALMGood for the Goose Products, LLC2786cec8-0b8e-9c83-e063-6394a90ab3382025-10-23WarningsExact identifier
application number: M020
Calendula Essential Hydrating Broad Spectrum SPF 30 SunscreenZINC OXIDENaturopathica Holistic Health41d75815-e281-bf88-e063-6294a90afeff2025-10-23WarningsExact identifier
application number: M020
Thrive Daily Sunscreen For Sensitive Skin SPF 30ZINC OXIDEThrive Natural Care, Inc128e1a3a-df40-f51c-e063-6394a90a19022025-10-23WarningsExact identifier
application number: M020
Thrive Bodyshield 50 SPF 50ZINC OXIDEThrive Natural Care, Inc12d9e1d0-c59c-f770-e063-6294a90a81912025-10-23WarningsExact identifier
application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Cream BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.2861453a-12e9-faeb-e063-6394a90a527c2025-10-23WarningsExact identifier
application number: M020
Good Defense Daily Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEOffspring Beauty Co.2a462e60-6353-f791-e063-6294a90a62e32025-10-23WarningsExact identifier
application number: M020
Skin Solution Multi-Serum Skin Tint SPF 40ZINC OXIDEOffspring Beauty Co.2d598f5d-d23f-6d54-e063-6294a90a778d2025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic KidsZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36c7a1be-87e5-1f87-e063-6394a90ad8762025-10-23WarningsExact identifier
application number: M020
Aussiezinc Mineral Sunscreen SPF50 BabyZINC OXIDEVeganic SKN Limited16cc5178-e4c7-38eb-e063-6294a90a66de2025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic EverydayZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36c9e96f-0299-095b-e063-6394a90a411d2025-10-23WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Anti-Aging - Light TintZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36c9f293-58c8-1a6f-e063-6394a90adc1f2025-10-23WarningsExact 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