Home NDC 58443-0601 NO-AD
Product NDC 58443-0601
11-digit product format 584430601
Labeler code 58443
Product ID 58443-0601_ee29e813-fea9-3119-e053-2995a90ae4b2
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-09-09
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 29 g/mL; g/mL; g/mL; g/mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 281 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join H.E.B. Mineral Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE H.E.B. c5279caf-3af9-d163-e053-2995a90a943b 2024-10-15 Warnings Exact identifier application number: M020 HEB Face 50 Clear Zinc Sunscreen OCTOCRYLENE, ZINC OXIDE H.E.B. f6e3c883-0087-dcd6-e053-6394a90a1272 2024-10-15 Warnings Exact identifier application number: M020 HEB Mineral Sunscreen SPF 50 ZINC OXIDE H.E.B. de99343b-c74c-3f43-e053-2995a90ac9dd 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 55 Babies and Kids Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. f5660a97-57c8-61c7-e053-2995a90a0164 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 362f726b-d52b-4dae-ade6-a47de47697ef 2024-10-15 Warnings Exact identifier application number: M020 HEB Sensitive 50 Mineral Sensitive Skin Sunscreen For Face ZINC OXIDE H.E.B. dfb43fc5-4968-f999-e053-2a95a90a0819 2024-10-15 Warnings Exact identifier application number: M020 H.E.B BABY SPF 50 SUNSCREEN H.E.B 61273611-ab7a-4216-aebe-2c8d89660281 2024-10-15 Warnings Exact identifier application number: M020 H.E.B BANANA SPF 50 SUNSCREEN H.E.B b9a9837a-094b-4a57-a50c-5c1437deda7b 2024-10-15 Warnings Exact identifier application number: M020 HEB Solutions Sunscreen SPORT SPF 100 LOTION H.E.B 9e3ea66c-d6a0-49ca-a3c0-8175e0617453 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 50 LOTION H.E.B 12c76c72-4411-48d5-b79b-c58703bf1fdd 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 50 CONTINUOUS SPRAY H.E.B 86ad5d30-f700-42a2-b810-dd2e3ed0f2d8 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 1f8d4f91-9eb9-41de-9066-a7a08c7ff84f 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 100 CONTINUOUS SPRAY H.E.B be80244d-da6d-4d37-b228-4d3fac335caf 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen KIDS SPF 50 LOTION SPRAY H.E.B 9b43c5d5-c279-4ae3-843e-1451f7324216 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 50 CONTINUOUS SPRAY H.E.B 2e183ba8-1b83-4211-bc08-dbdcee942ce9 2024-10-15 Warnings Exact identifier application number: M020 EQUALINE KIDS SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE United Natural Foods, Inc. dba UNFI e46cb6e3-ea8d-3c2d-e053-2a95a90a0bf6 2024-10-15 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE SUNSCREEN Bentley Laboratories LLC 782a8641-7e6a-413b-a2ed-0efeb36c48a7 2024-10-15 Warnings Exact identifier application number: M020 H.E.B MANGO SPF 50 SUNSCREEN H.E.B 35898f07-2973-461a-91b8-095aa4cf38ee 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 30 CONTINUOUS SPRAY H.E.B 8b6d0c0d-485b-4428-91e5-5befcac18d5d 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 50 CONTINUOUS SPRAY H.E.B 5fd3d730-d916-48f4-bb94-62d40d181280 2024-10-15 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 58443-0601-3 58443060103 89 mL in 1 TUBE (58443-0601-3) 89 ml 2021-09-09 0000-00-00 No No Current