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 133 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Matte CE Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b72d14-b69b-e9dd-e063-6394a90a748e 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SCIENCE CEUTICALS, LLC 369b20e2-2cad-e047-e063-6294a90a1bba 2025-12-11 Exact identifier application number: M020 Tinted Mineral Matte CE Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b60880-5fe1-b78f-e063-6294a90a748d 2025-12-11 Exact identifier application number: M020 Sheer Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b51190-6a6d-c5e0-e063-6394a90ae875 2025-12-11 Exact identifier application number: M020 Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 374fae34-41b9-4cab-e063-6394a90a9b1d 2025-12-11 Exact identifier application number: M020 Z Bloc ZINC OXIDE The Maui Medical Group, Inc 34b64eb5-a91f-de43-e063-6294a90a8043 2025-12-11 Exact identifier application number: M020 Sheer Tinted Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b6e8d0-6235-dac2-e063-6394a90afefd 2025-12-11 Exact identifier application number: M020 Tinted Sunscreen Face Primer TITANIUM DIOXIDE, ZINC OXIDE LIV BODY AND BEAUTY 374f6b79-2ac4-61cf-e063-6394a90a699b 2025-12-11 Exact identifier application number: M020 Non Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 375008f2-8dd4-aa31-e063-6394a90a5be8 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection ZINC OXIDE The Maui Medical Group, Inc 34b96d82-7fcf-e452-e063-6394a90a781b 2025-12-11 Exact identifier application number: M020 Daily Sun Defense TITANIUM DIOXIDE, ZINC OXIDE LIV BODY AND BEAUTY LLC 3750c2fd-c5cc-fd00-e063-6394a90aeb89 2025-12-11 Exact identifier application number: M020 Non Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 3750ffbf-a82d-b4b9-e063-6294a90a7d68 2025-12-11 Exact identifier application number: M020 The Block ZINC OXIDE ELITE ESTHETICS BY NICOLE CAROLINE LLC 34a6b17e-6e9e-3f2c-e063-6294a90a1c32 2025-12-11 Exact identifier application number: M020 SPF 40 Broad Spectrum Non-Tinted ZINC OXIDE Teton Dermatology Holdings, Inc. 35093797-008b-b265-e063-6294a90a9949 2025-12-11 Exact identifier application number: M020 Tinted Zinc Protection ZINC OXIDE Teton Dermatology Holdings, Inc. 3508d5a8-9d3c-51d1-e063-6394a90abc8e 2025-12-11 Exact identifier application number: M020 SPF 40 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE Teton Dermatology Holdings, Inc. 35081ce0-2203-ab86-e063-6294a90aefd5 2025-12-11 Exact identifier application number: M020 Antioxidant SPF ZINC OXIDE Teton Dermatology Holdings, Inc. 3509a916-f3e1-9c53-e063-6394a90a5bff 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen Tinted ZINC OXIDE HALEM DERMATOLOGY PLLC 35bb4953-ca8c-e927-e063-6394a90a1a31 2025-12-11 Exact identifier application number: M020 Lip Protection TITANIUM DIOXIDE, ZINC OXIDE Teton Dermatology Holdings, Inc. 3509eea7-f966-2080-e063-6294a90aeeb5 2025-12-11 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HALEM DERMATOLOGY PLLC 35bce44e-d9f4-9279-e063-6394a90a6453 2025-12-11 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