Home NDC 65692-0307 Broad Spectrum SPF 15 Coconut Lip Balm
Product NDC 65692-0307
11-digit product format 656920307
Labeler code 65692
Product ID 65692-0307_0decf6f7-de38-4584-8bfe-83596fb81e25
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form STICK
Route TOPICAL
Labeler Raining Rose, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-27
Substance ZINC OXIDE
Active strength 35 mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Broad Spectrum SPF 15 Coconut Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 35 mg/g
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65692-0307-1 Broad Spectrum SPF 15 Coconut Lip Balm 4.25 g in 1 TUBE STICK 4.25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65692-0307 BROAD SPECTRUM SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [RAINING ROSE, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231104_2a03abc4-824b-438d-acc5-469853057679.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 65692-0307-1 65692030701 4.25 g in 1 TUBE (65692-0307-1) 4.25 g 2021-04-27 0000-00-00 No No Current