Home NDC 53208-800 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53208-800-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53208-800-01 0efc9e666f02…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 Ingredient Strength TITANIUM DIOXIDE 2.285 g/50mL ENSULIZOLE 1.75 g/50mL OCTINOXATE 3.5 g/50mL ZINC OXIDE 5.825 g/50mL OCTISALATE 2.25 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53208-800-01 Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 2 in 1 BOX LOTION 2 3 53208-800-01 Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 50 mL in 1 TUBE LOTION 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53208-800 BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50 (ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LG H&H CO., LTD.] 3 Current NDC, Legacy NDC, 2 package rows 20250125_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 5 of 361 · 7,213 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hawaiian Tropic AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 5991466a-e729-16b7-e063-6394a90a11ff 2026-08-21 Warnings Exact identifier application number: M020 Avobenzone, Homosalate, Octisalate AVOBENZONE, HOMOSALATE, OCTISALATE Topco Associates LLC 597b78df-83cb-1b21-e063-6294a90a56a8 2026-08-20 Warnings, Adverse reactions Exact identifier application number: M020 Sunski Base Camp Face and Body Sunscreen SPF 45 HOMOSALATE, OCTISALATE, AVOBENZONE Stewart Charley Ventures, LLC 2fc45f85-a6f8-4893-8b34-4db5e39cb615 2026-08-20 Warnings Exact identifier application number: M020 Sweat Resistant Sunscreen Body Original TITANIUM DIOXIDE, ZINC OXIDE Clutch, Inc. 4bbde755-e312-123e-e063-6294a90a467f 2026-08-20 Warnings Exact identifier application number: M020 Sunscreen BROAD SPECTRUM SPF 30 Concierge Choice LLC 5980055b-493e-4763-e063-6294a90a570f 2026-08-20 Warnings Exact identifier application number: M020 Lip Balm SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Skin Script, LLC 20c5fde7-ee8f-4b74-e063-6394a90a93ec 2026-08-19 Warnings Exact identifier application number: M020 Aloe UP .5OZ SPF 50 MINERAL Sunscreen ZINC OXIDE 14.69% Aloe Care International, LLC 6ad80af3-78cd-4211-a5f2-68531aae264a 2026-08-19 Warnings Exact identifier application number: M020 Utu Broad Spectrum SPF 50 Tinted Sunscreen-Stick ZINC OXIDE Utu Co 596e17d3-3064-1cda-e063-6294a90af963 2026-08-19 Warnings Exact identifier application number: M020 Mineral sunscreen MINERAL SUNSCREEN Guangzhou Origin Beauty Cosmetics Co., Ltd. 59713657-a7ef-1aee-e063-6394a90a326e 2026-08-19 Warnings Exact identifier application number: M020 The Naked Bee SPF 50 Mineral Sunscreen ZINC OXIDE 14.69% The Naked Bee f820a9be-c94d-4fd5-b202-2dda5746a82a 2026-08-18 Warnings Exact identifier application number: M020 The Naked Bee SPF 50 Mineral Sunscreen ZINC OXIDE 20% The Naked Bee 7dd2b1cd-e229-4eeb-8122-46fde5af1091 2026-08-18 Warnings Exact identifier application number: M020 Sun Zapper - Baby pure zinc sunscreen SPF30 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 3ee52faa-64a8-4bdf-e063-6294a90a65cf 2026-08-17 Warnings Exact identifier application number: M020 Sun Zapper - Face pure zinc sunscreen SPF30 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 3ee4feb3-6966-67f9-e063-6394a90a16d5 2026-08-17 Warnings Exact identifier application number: M020 HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN ZINC OXIDE,TITANIUM DIOXIDE Guangzhou Tata Biotechnology Co., Ltd. 4339df13-77d3-31a1-e063-6394a90a5208 2026-08-17 Warnings Exact identifier application number: M020 Soleil Defense Sunscreen BROAD SPECTRUM SPF 30 AMARA MED SPA LLC 594244b1-db3b-002b-e063-6394a90a0329 2026-08-17 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 HAMBLIN DERMATOLOGY 5942e64c-416e-7525-e063-6394a90a2839 2026-08-17 Warnings Exact identifier application number: M020 Protect Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 Opal Day Spa 5943413a-48e1-0bdf-e063-6294a90a2fff 2026-08-17 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 MedSpa By Beauty Bar LLC 5943ba3d-688e-9e9c-e063-6294a90afa9a 2026-08-17 Warnings Exact identifier application number: M020 Sunscreen BROAD SPECTRUM SPF 30 Charleston Dermatology, P.C. 59440f7f-4213-6e2b-e063-6394a90af483 2026-08-17 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 CORBY, JR., TERRY L. 594443fd-8e27-4ec6-e063-6294a90a3ff0 2026-08-17 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53208-800-01 53208080001 2 TUBE in 1 BOX (53208-800-01) / 50 mL in 1 TUBE 2 tube 2020-04-27 0000-00-00 No No Current