Home NDC 68078-028 Lip Shine SPF35 Sunscreen
Product NDC 68078-028
11-digit product format 680780028
Labeler code 68078
Product ID 68078-028_10c37e69-e203-43fb-a8c3-50be826a74f1
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LIQUID
Route TOPICAL
Labeler Colorescience
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-07-01
Substance ZINC OXIDE
Active strength 66 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 Lip Shine SPF35 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 66 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68078-028-01 Lip Shine SPF35 Sunscreen 4 mL in 1 TUBE, WITH APPLICATOR LIQUID 4 3 68078-028-01 Lip Shine SPF35 Sunscreen 1 in 1 CARTON LIQUID 1 3 68078-028-02 Lip Shine SPF35 Sunscreen 1.7 mL in 1 TUBE, WITH APPLICATOR LIQUID 1.7 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68078-028 LIP SHINE SPF35 SUNSCREEN (ZINC OXIDE) LIQUID [COLORESCIENCE] 3 Current NDC, Legacy NDC, 3 package rows 20241215_3a6506c4-1ba9-493a-a4c8-e5f9c60d221b.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 Marketing end Sample Exclude flag Status 68078-028-01 68078002801 1 TUBE, WITH APPLICATOR in 1 CARTON (68078-028-01) / 4 mL in 1 TUBE, WITH APPLICATOR 2017-07-01 0000-00-00 No No Current 68078-028-02 68078002802 1.7 mL in 1 TUBE, WITH APPLICATOR (68078-028-02) 1.7 ml 2017-07-01 0000-00-00 No No Current