Home NDC 67879-309 SUN THERAPE FACE AND BODY
Product NDC 67879-309
11-digit product format 678790309
Labeler code 67879
Product ID 67879-309_1f947bfc-53ab-1cbe-e063-6294a90aebb1
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form LOTION
Route TOPICAL
Labeler PHARMAGEL INTERNATIONAL INC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-06-18
Substance OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE
Active strength 7.5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL
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 SUN THERAPE FACE AND BODY
Brand name suffix SPF-35
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7.5 g/100mL OCTISALATE 5 g/100mL OXYBENZONE 3 g/100mL AVOBENZONE 3 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 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 67879-309-12 SUN THERAPE FACE AND BODYSPF-35 125 mL in 1 TUBE LOTION 125 8 67879-309-51 SUN THERAPE FACE AND BODYSPF-35 1 in 1 BOX LOTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67879-309 SUN THERAPE FACE AND BODY SPF-35 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC] 8 Current NDC, Legacy NDC, 2 package rows 20240815_6a96623f-c37c-4e67-925e-f133461d726d.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 218 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Halo Glow Skin Tint SPF 50 84507 ZINC OXIDE e.l.f. Cosmetics, Inc. 31314118-0fd6-5549-e063-6394a90a9d1f 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84506 ZINC OXIDE e.l.f. Cosmetics, Inc. 313119be-c1f2-4cb0-e063-6294a90a03ca 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84516 ZINC OXIDE e.l.f. Cosmetics, Inc. 312dd439-5cc8-e034-e063-6394a90a5c76 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84504 ZINC OXIDE e.l.f. Cosmetics, Inc. 223efabb-d018-c337-e063-6394a90a5605 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 Marketing end Sample Exclude flag Status 67879-309-12 67879030912 125 mL in 1 TUBE 125 ml Historical 67879-309-51 67879030951 1 TUBE in 1 BOX (67879-309-51) / 125 mL in 1 TUBE (67879-309-12) 1 tube 2016-06-10 0000-00-00 No No Current