Home NDC 71160-331 SPF 30 Sunscreen
Product NDC 71160-331
11-digit product format 711600331
Labeler code 71160
Product ID 71160-331_0d7021f4-3029-3554-e063-6294a90a64d4
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form LOTION
Route TOPICAL
Labeler Tekweld Solutions, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-20
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 30; 100; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
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 SPF 30 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 100 mg/mL OCTOCRYLENE 100 mg/mL OCTISALATE 50 mg/mL
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 Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71160-331 SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [TEKWELD SOLUTIONS, INC.] 1 Current NDC, 8 package rows 20231228_ea9f4d57-b00c-48ce-b833-9690be98bffd.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71160-331-30 71160033130 1 BOTTLE in 1 CARTON (71160-331-30) / 30 mL in 1 BOTTLE 1 bottle 2023-12-20 No No Current 71160-331-31 71160033131 1 BOTTLE in 1 CARTON (71160-331-31) / 30 mL in 1 BOTTLE 1 bottle 2023-12-20 No No Current 71160-331-32 71160033132 1 BOTTLE in 1 CARTON (71160-331-32) / 30 mL in 1 BOTTLE 1 bottle 2023-12-20 No No Current 71160-331-60 71160033160 1 BOTTLE in 1 CARTON (71160-331-60) / 60 mL in 1 BOTTLE 1 bottle 2023-12-20 No No Current