Home NDC 85301-201 Tinted Physical Block Sunscreen
Product NDC 85301-201
11-digit product format 853010201
Labeler code 85301
Product ID 85301-201_4586b1ca-b20c-f78a-e063-6394a90a2523
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Tucson Acne Clinic
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-22
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 38; 80 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 Tinted Physical Block Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 38 mg/g TITANIUM DIOXIDE 80 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85301-201-85 Tinted Physical Block Sunscreen 85 g in 1 BOTTLE, PUMP CREAM 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85301-201 TINTED PHYSICAL BLOCK SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [TUCSON ACNE CLINIC] 1 Current NDC, 1 package rows 20250323_30dc6e23-ecca-ed0b-e063-6294a90a7951.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 221 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lip Balm SPF15 Vanilla LIP BALM SPF15 VANILLA LS Promotions Inc 312d0dc5-3933-ecfe-e063-6294a90a9b66 2025-03-25 Warnings Exact identifier application number: M020 Lip Balm SPF15 Blueberry Cobbler LIP BALM SPF15 BLUEBERRY COBBLER LS Promotions Inc 312fb7b0-86a9-ca88-e063-6294a90a76c8 2025-03-25 Warnings Exact identifier application number: M020 Lip Balm SPF15 Peppermint LIP BALM SPF15 PEPPERMINT LS Promotions Inc 3130be1c-0167-2389-e063-6394a90aa61d 2025-03-25 Warnings Exact identifier application number: M020 Drs. pharmacy sunscreen SPF 30 SUNSCREEN SPF 30 OL PHARMA TECH LLC. (Drs. Pharmacy) 052dea5d-a775-8dc2-e063-6294a90a4f19 2025-03-25 Warnings Exact identifier application number: M020 Drs. pharmacy sunscreen SPF 50 SUNSCREEN SPF 50 OL PHARMA TECH LLC. (Drs. Pharmacy) 0def5c19-b088-2ffb-e063-6394a90aa109 2025-03-25 Warnings Exact identifier application number: M020 Drs. pharmacy sunscreen SPF 70 SUNSCREEN SPF 70 OL PHARMA TECH LLC. (Drs. Pharmacy) 0def6fa1-b028-fad5-e063-6394a90a1913 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84521 ZINC OXIDE e.l.f. Cosmetics, Inc. 31329426-d952-ee5d-e063-6294a90a55f4 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84520 ZINC OXIDE e.l.f. Cosmetics, Inc. 31328845-9a67-d237-e063-6294a90a2a7f 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84519 ZINC OXIDE e.l.f. Cosmetics, Inc. 31327ea3-affd-ca13-e063-6294a90a7238 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84517 ZINC OXIDE e.l.f. Cosmetics, Inc. 3132641a-e593-a9e8-e063-6294a90acc80 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84518 ZINC OXIDE e.l.f. Cosmetics, Inc. 3132669c-e104-ae1e-e063-6294a90aee7f 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84514 ZINC OXIDE e.l.f. Cosmetics, Inc. 31324410-3142-89e1-e063-6294a90a22ee 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84515 ZINC OXIDE e.l.f. Cosmetics, Inc. 31324ff6-a091-a51b-e063-6294a90a1dbb 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84513 ZINC OXIDE e.l.f. Cosmetics, Inc. 3131d155-4c23-db51-e063-6294a90a0019 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50-84505 ZINC OXIDE e.l.f. Cosmetics, Inc. 312d171d-b057-96d1-e063-6394a90ac429 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84511 ZINC OXIDE e.l.f. Cosmetics, Inc. 313175f3-e42a-b2a7-e063-6294a90abcb7 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84510 ZINC OXIDE e.l.f. Cosmetics, Inc. 3131696a-a37a-908b-e063-6294a90a5e95 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84512 ZINC OXIDE e.l.f. Cosmetics, Inc. 31318380-79fe-c0e0-e063-6294a90af4fc 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84508 ZINC OXIDE e.l.f. Cosmetics, Inc. 3131512e-f97b-718e-e063-6294a90aa3c1 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84509 ZINC OXIDE e.l.f. Cosmetics, Inc. 313147bc-0095-7cbd-e063-6294a90a7d28 2025-03-25 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 85301-201-85 85301020185 85 g in 1 BOTTLE, PUMP (85301-201-85) 85 g 2024-01-22 No No Current