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 182 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08f0436b-85b6-5099-e063-6294a90a4c2e 2025-10-09 Warnings Exact identifier application number: M020 CoreTex Professional Outdoor Skin Protection Wallet CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET CoreTex Products Inc f57bc089-405b-cdcd-e053-2995a90a9d12 2025-10-09 Warnings Exact identifier application number: M020 Mist Me SPF-40 ZINC OXIDE Cove Suncare LLC b7f09089-54a4-4f60-b632-e3f4321313ec 2025-10-09 Warnings Exact identifier application number: M020 Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Allergan, Inc. 29817fdc-f14c-4013-a8ed-4367f3b2867c 2025-10-09 Warnings Exact identifier application number: M020 Skinny Dip SPF-50 ZINC OXIDE Cove Suncare LLC 7bef2966-9351-4ea6-aeed-0d568376d86b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0ba2e9-126f-13c0-e063-6394a90aa6a4 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 08997bd4-d6b9-fffc-e063-6294a90a77ae 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Kenvue Brands LLC 75f81b2d-cabc-443f-b4b5-76bd2321826b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 1390f863-709e-412b-9a25-b65217844e44 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC ccc2e40b-5301-4055-8a89-47366687cfb7 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0dd2e4-3dda-c872-e063-6294a90a20a3 2025-10-08 Warnings Exact identifier application number: M020 ScalpHair MistSunscreen SPF30 COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30 COOLA LLC c7d2098f-6fdf-68e5-e053-2a95a90a1898 2025-10-08 Warnings Exact identifier application number: M020 Block Party SPF-50 ZINC OXIDE Cove Suncare LLC 24ffb6ec-d922-40c0-b325-c15f8433027a 2025-10-08 Warnings Exact identifier application number: M020 Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE The Natural SKN Company 40945805-6f2e-74a1-e063-6394a90a04a3 2025-10-07 Warnings Exact identifier application number: M020 ProtecTINT 10N HOMOSALATE, OCTISALATE, ZINC OXIDE Supergoop, LLC 0801287f-0df5-4303-e063-6394a90a503b 2025-10-07 Warnings Exact identifier application number: M020 Vertra Pearl White Face Stick SPF 50 PADIMATE O, TITANIUM DIOXIDE Eai-jr 286, Inc b69a75e0-8724-35ae-e053-2a95a90a5f34 2025-10-07 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE EAI-JR 286, Inc. b9ea12e8-6ed9-d805-e053-2a95a90aa107 2025-10-07 Warnings Exact identifier application number: M020 SPF50 Sunscreen SUNSCREEN KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD b3cde609-7d62-2ac7-e053-2a95a90a26b3 2025-10-07 Exact identifier application number: M020 Summer Face Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC fe256ff4-cb92-4262-8ab9-7cc912e0af22 2025-10-06 Warnings Exact identifier application number: M020 Sun Veil Broad Spectrum SPF50 ZINC OXIDE MONAT GLOBAL CORP 3ba28de7-74a2-5cde-e063-6394a90add26 2025-10-06 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