Home NDC 63354-703 Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50
Product NDC 63354-703
11-digit product format 633540703
Labeler code 63354
Product ID 63354-703_42ee8850-2a6a-c682-e063-6394a90a0dbb
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form OIL
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-01
Marketing end 2027-10-01
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 6.7; 4.9 g/100g; g/100g
NDC exclude flag No
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 Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 6.7 g/100g TITANIUM DIOXIDE 4.9 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63354-703-12 Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50 100 g in 1 BOTTLE OIL 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-703 HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241103_efcd52c2-4208-46a1-e053-2a95a90a857d.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 63354-703-12 63354070312 100 g in 1 BOTTLE (63354-703-12) 100 g 2022-10-01 2027-10-01 No No Current