Home NDC 69630-004 Zinc Oxide 20%
Product NDC 69630-004
11-digit product format 696300004
Labeler code 69630
Product ID 69630-004_4db2b8a1-b627-9f7b-e063-6394a90a1fa9
Type HUMAN OTC DRUG
Nonproprietary name Sunscreen SPF 50
Dosage form LOTION
Route TOPICAL
Labeler The Soleil Group, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-09
Substance ZINC OXIDE
Active strength 20 g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Zinc Oxide 20%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 g/100mL
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 69630-004-01 Zinc Oxide 20% 1 in 1 CARTON LOTION 1 2 69630-004-01 Zinc Oxide 20% 16 mL in 1 BOTTLE LOTION 16 2
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 180 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Premium Moisturizing Sunscreen Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4346f7a-3642-05d8-e053-2a95a90a013d 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4206dad-6a17-2f56-e053-2a95a90a69dc 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f434089c-126f-441c-e053-2995a90ab0c7 2025-10-09 Warnings Exact identifier application number: M020 BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis) ZINC OXIDE Napoleon PerdisCosmetic Pty Ltd be64bb40-b1a9-2308-e053-2a95a90a69c8 2025-10-09 Warnings Exact identifier application number: M020 Organys Open Formula Sheer ZINC OXIDE Organys Beauty 0b3ab551-cb66-cf86-e063-6394a90a7ab4 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift Mineral SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Spa de Soleil 40c03d65-8d09-371a-e063-6294a90a7ac6 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made Sheer ZINC OXIDE Organys Beauty 0b39f550-bd34-509d-e063-6294a90a51d0 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 0b37a73b-73ca-501f-e063-6294a90a6291 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 09b8b8c0-4066-9cbe-e063-6394a90aca24 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift Mineral SPF 30 TITANIUM DIOXIDE Spa de Soleil 40c0e0d2-2c1d-e629-e063-6394a90a5aaf 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 3) ZINC OXIDE Resette, Inc dc89ab76-da32-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 4) ZINC OXIDE Resette, Inc dc89ab0b-d53e-983f-e053-2a95a90a127f 2025-10-09 Warnings Exact identifier application number: M020 Petroleum-Free Lip Balm OCTINOXATE AND OXYBENZONE Medline Industries, LP 6125d98a-6fc7-4f50-924e-3b1f7ee951f4 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 1) ZINC OXIDE Resette, Inc dc89429a-022c-dd10-e053-2a95a90ac26a 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 2) ZINC OXIDE Resette, Inc dc89ab76-da2f-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift SPF 50 Clear Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Spa de Soleil 40c11b19-fc91-2033-e063-6394a90a5a5f 2025-10-09 Warnings Exact identifier application number: M020 Black Girl Sunscreen Make It Mineral Baby ZINC OXIDE Black Girl Sunscreen 302bccc6-7bf3-cc69-e063-6294a90a625c 2025-10-09 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08f0436b-85b6-5099-e063-6294a90a4c2e 2025-10-09 Warnings Exact identifier application number: M020 CoreTex Professional Outdoor Skin Protection Wallet CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET CoreTex Products Inc f57bc089-405b-cdcd-e053-2995a90a9d12 2025-10-09 Warnings Exact identifier application number: M020 Mist Me SPF-40 ZINC OXIDE Cove Suncare LLC b7f09089-54a4-4f60-b632-e3f4321313ec 2025-10-09 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69630-004-01 69630000401 1 BOTTLE in 1 CARTON (69630-004-01) / 16 mL in 1 BOTTLE 1 bottle 2025-12-01 No No Current