Home NDC 85585-212 Really Great Lip Shield
Product NDC 85585-212
11-digit product format 855850212
Labeler code 85585
Product ID 85585-212_46163558-0bb6-6edb-e063-6294a90a36ff
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-26
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 55; 40 mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Really Great Lip Shield
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 55 mg/g TITANIUM DIOXIDE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
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 85585-212-45 Really Great Lip Shield 4.5 g in 1 CYLINDER STICK 4.5 2 85585-212-45 Really Great Lip Shield 1 in 1 CARTON STICK 1 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 184 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVE AVOBENZONE, HOMOSALATE, OCTISALATE MDSolarSciences 3fa810b0-0211-f2a7-e063-6294a90a0b72 2025-09-25 Warnings Exact identifier application number: M020 SUN BUFF SPF 30 MINERAL SUNSCREEN ZINC OXIDE/TITANIUM DIOXIDE SPF Ventures, LLC 3f874062-ebab-8993-e063-6294a90abfc5 2025-09-24 Warnings Exact identifier application number: M020 HygieneLab Face and Body Mineral Sunscreen SPF 50 ZINC OXIDE HYGIENELAB, INC 7db103da-b434-433a-a18f-a727165640c0 2025-09-24 Warnings Exact identifier application number: M020 Eve Lom Daily Protection Broad Spectrum SPF 50 Sunscreen HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENE Space Brands Limited 0e2c9ffb-036d-49c5-abdb-2ee8888df318 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint DG6 ZINC OXIDE PUR Minerals 3f8e97a7-2023-ba9c-e063-6294a90ac9c9 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint TN7 ZINC OXIDE PUR Minerals 3f0717c7-f43f-e3b1-e063-6394a90a74dd 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint TN2 ZINC OXIDE PUR Minerals 3f06ed2f-f43f-53d4-e063-6294a90af0dd 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint MN4 ZINC OXIDE PUR Minerals 3f06f618-f7b2-53d0-e063-6294a90a829c 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint MN3 ZINC OXIDE PUR Minerals 3f06df49-5ed2-44ca-e063-6294a90a1fda 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint LN2 ZINC OXIDE PUR Minerals 3f069dfe-289d-8d3b-e063-6394a90a0496 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint LG3 ZINC OXIDE PUR Minerals 3f06ec3e-fc15-9f7b-e063-6394a90a0733 2025-09-24 Warnings Exact identifier application number: M020 Volition Prismatic Luminizing Shield ZINC OXIDE Volition 1a633c24-b9d9-4732-e063-6294a90af4c0 2025-09-24 Warnings Exact identifier application number: M020 Alleyoop Sunsational Broad Spectrum ZINC OXIDE NewAlley Innovations Inc 248419c4-8044-402c-e063-6394a90a00f8 2025-09-24 Warnings Exact identifier application number: M020 Aloe Up SPF 30 coco-mango mist AVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0% Aloe Up f7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e92 2025-09-24 Warnings Exact identifier application number: M020 pavise Dynamic Age Defense ZINC OXIDE B.A.I BIOSCIENCES, INC f4e9f95c-6b1e-d5f7-e053-2a95a90a93ce 2025-09-24 Warnings Exact identifier application number: M020 Aloe Up SPF 50 coco-mango mist AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0% Aloe Up d535b711-c54e-4447-9907-ca9d829d1319 2025-09-24 Warnings Exact identifier application number: M020 ESPOIR WATER SPLASH SUN SERUM HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE ESPOIR Corporation 1c4e7ba2-05e8-f949-e063-6394a90a699d 2025-09-23 Warnings Exact identifier application number: M020 Banana Boat ZINC OXIDE Edgewell Personal Care Brands LLC 1d11c3d0-5f4e-0ed0-e063-6294a90abc75 2025-09-23 Warnings Exact identifier application number: M020 Dewscreen Daily Hydrator and Primer SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3f7c84e3-0e4f-b7e9-e063-6294a90a1295 2025-09-23 Warnings Exact identifier application number: M020 Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 15d8574d-94bb-4842-e063-6394a90a15e6 2025-09-23 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 85585-212-45 85585021245 1 CYLINDER in 1 CARTON (85585-212-45) / 4.5 g in 1 CYLINDER 1 cylinder 2022-05-26 No No Current