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 26 of 357 · 7,139 matching rows.
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