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 325 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30 ZINC OXIDE Naturally Uncommon, LLC af882b7e-c64f-0de6-e053-2995a90a7ca0 2023-11-09 Warnings Exact identifier application number: M020 EltaMD UV AOX Mist ZINC OXIDE SUNSCREEN CP Skin Health Group, Inc 1062efb1-a638-4323-88f8-f2f98a5b996e 2023-11-09 Warnings Exact identifier application number: M020 EltaMD UV Active ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN CP Skin Health Group, Inc. 2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2 2023-11-09 Warnings Exact identifier application number: M020 Physical Sunscreen SPF50 80 min WR 159-100 TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN Swiss-American CDMO, LLC 0cca7b65-e24a-429c-b157-5f4e343424ab 2023-11-09 Warnings Exact identifier application number: M020 Private Label Sunscreen SPF35 40min WR RE126-202 HOMOSALATE, ZINC OXIDE SUNSCREEN Swiss-American CDMO, LLC 254fa69f-2413-47e8-bc9b-5b7b0b59a5c8 2023-11-09 Warnings Exact identifier application number: M020 PLANTSCRIPTION SPF 25 POWER ANTI-AGING oil FREE BROAD SPECTRUM AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE ORIGINS NATURAL RESOURCES INC. 91c14980-ba63-4705-a465-581fe11d0a98 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0N OCTISALATE, TITANIUM DIOXIDE Guerlain a20dc51a-1f6c-4a6d-97f6-2f048e0689a0 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5C OCTISALATE, TITANIUM DIOXIDE Guerlain a6c8b20f-6377-443b-a89b-8b5d40c65ad8 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5N OCTISALATE, TITANIUM DIOXIDE Guerlain b6591b2e-9e55-4f25-958c-f36f1ef85749 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5N OCTISALATE, TITANIUM DIOXIDE Guerlain 6e2ae7cb-c390-4996-95e8-ae8fadefa8bd 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1N OCTISALATE, TITANIUM DIOXIDE Guerlain a143c8cb-185c-4fd8-a901-3c0d9ffb8290 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1C OCTISALATE, TITANIUM DIOXIDE Guerlain 3d6e438d-9ea4-4253-9153-748d3c974265 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2N OCTISALATE, TITANIUM DIOXIDE Guerlain 173aeaab-a286-48ed-9033-10b13f547bbd 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5N OCTISALATE, TITANIUM DIOXIDE Guerlain d877575a-25f3-49bd-b403-ecf6a1eb483a 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5N OCTISALATE, TITANIUM DIOXIDE Guerlain 24e1e576-9edd-45aa-a883-2a2d18a1cb5e 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6N OCTISALATE, TITANIUM DIOXIDE Guerlain a8fffe38-5f90-4078-b553-30036659a2ee 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7N OCTISALATE, TITANIUM DIOXIDE Guerlain bfa2b2be-958c-439f-b363-2623df2b8501 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3N OCTISALATE, TITANIUM DIOXIDE Guerlain 15f73322-0b27-4412-b368-84bc768f55e8 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2W OCTISALATE, TITANIUM DIOXIDE Guerlain 51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4N OCTISALATE, TITANIUM DIOXIDE Guerlain b70b8ffc-091a-4969-86a7-6c3e1b9b9d74 2023-11-08 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