Home NDC 85557-203 Prime and Protect
Product NDC 85557-203
11-digit product format 855570203
Labeler code 85557
Product ID 85557-203_46278184-553b-d003-e063-6394a90a8ce2
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Shannon Cornelsen-Lewandowski
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-03
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 80; 38 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Prime and Protect
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85557-203-15 Prime and Protect 1.5 g in 1 PACKET CREAM 1.5 2 85557-203-50 Prime and Protect 53 g in 1 BOTTLE, PUMP CREAM 53 2
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 39 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HYDRA SPF 34 HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE Drmtlgy, LLC 31e41ed5-8498-4e2d-928a-c15ca99775e4 2026-04-21 Warnings Exact identifier application number: M020 FORGESKIN MINERAL TALLOW SUNSCREEN GUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD 4fe913f4-b0be-dc53-e063-6294a90a363c 2026-04-20 Warnings Exact identifier application number: M020 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM AVOBENZONE, HOMOSALATE, OCTISALATE SEORIN COMPANY Co., Ltd. 228dcd68-aaba-0451-e063-6394a90a8ad0 2026-04-20 Warnings Exact identifier application number: M020 Biore Aqua Rich UV OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA f900db18-5fe2-1d74-e053-6394a90a3ca2 2026-04-20 Warnings Exact identifier application number: M020 Biore UV Aqua Rich OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA 2bc23bb5-86bb-7915-e063-6394a90a9d72 2026-04-20 Warnings Exact identifier application number: M020 ETUDE SunPrise Mild Airy Finish Sunstick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ETUDE CORPORATION 25abc744-5b62-acb4-e063-6394a90af110 2026-04-19 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b05e-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b060-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7d9f4-986f-70f7-e053-2a95a90a4f8a 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c81845-afcb-18ac-e053-2a95a90abdbe 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c83245-a40c-8f05-e053-2a95a90a0521 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c84047-fd3b-ea66-e053-2a95a90ae9aa 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c623aa-3846-b7f4-e053-2995a90aecb5 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c585ff-88de-e29c-e053-2a95a90af4d4 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c852de-4c36-6d93-e053-2995a90aff61 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c86288-bb22-03b1-e053-2995a90a3161 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8742f-1060-48bc-e053-2995a90a31c2 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c4eedc-12a0-6418-e053-2a95a90a55e7 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8849a-6624-6987-e053-2a95a90a4546 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8ac70-a8c8-2f07-e053-2a95a90a3d01 2026-04-18 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85557-203-15 85557020315 1.5 g in 1 PACKET (85557-203-15) 1.5 g 2021-09-03 Yes No Current 85557-203-50 85557020350 53 g in 1 BOTTLE, PUMP (85557-203-50) 53 g 2021-09-03 No No Current