Home NDC 53675-203-00 Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick
Product NDC 53675-203
Requested package NDC 53675-203-00
11-digit product format 536750203
Labeler code 53675
Product ID 53675-203_098688fd-eb12-29d6-e063-6294a90ade41
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form STICK
Route TOPICAL
Labeler Aruba Aloe Balm NV
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-08
Substance ZINC OXIDE
Active strength 200 mg/mL
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 Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53675-203-00 Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick 30 mL in 1 CONTAINER STICK 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53675-203 SPORT BROAD SPECTRUM SPF50 WATER RESISTANT 80 MINUTES MINERAL SUNSCREEN UVA UVB PROTECTION STICK (ZINC OXIDE) STICK [ARUBA ALOE BALM NV] 2 Current NDC, Legacy NDC, 1 package rows 20231108_3201cc8b-5fee-4f3b-a826-e349786d1b32.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 337 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Artistry Beauty Balm Perfecting Primer SPF 35 Broad Spectrum Sunscreen ENSULIZOLE, OCTINOXATE, ZINC OXIDE Amway Corp 6aaec5a4-701e-4870-896d-f68f62448c7a 2023-10-21 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum Sunscreen TITANIUM DIOXIDE Amway Corp a83f1192-c6c7-4145-b5af-29202191db78 2023-10-21 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Buff L1W1 TITANIUM DIOXIDE Amway Corp cba2462d-71ec-4ecb-b05a-5208ff8e22ad 2023-10-21 Warnings Exact identifier application number: M020 ARTISTRY YOUTH XTEND Lifting Smoothing Foundation Broad Spectrum SPF 20 Sunscreen OCTINOXATE, OXYBENZONE Amway Corp 8cde14ae-b886-4bd2-b2bd-db604373984a 2023-10-21 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Brule L4W1 TITANIUM DIOXIDE Amway Corp 19d08a86-5a60-4633-8a3c-96bab9a17fcc 2023-10-21 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Chablis L1C1 TITANIUM DIOXIDE Amway Corp d17b1d46-478e-4f48-8fde-ac639bcdc492 2023-10-21 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Chiffon L2C1 TITANIUM DIOXIDE Amway Corp 750ca57c-e8e9-4be0-84b1-7f55487f7bf6 2023-10-21 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Cream L1W2 TITANIUM DIOXIDE Amway Corp 192dac09-2887-4622-b3d4-c6a9c16b4f88 2023-10-21 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Mink L6W1 TITANIUM DIOXIDE Amway Corp af6d38d5-69ab-4d7e-b534-b2c2bcf36847 2023-10-21 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Ochre L2N1 TITANIUM DIOXIDE Amway Corp 7f545d32-b38c-4f6a-a413-7f29e1aa2bc3 2023-10-21 Warnings Exact identifier application number: M020 CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE CLINIQUE LABORATORIES LLC 2e9463df-1c71-465f-9820-6cedefe07ad7 2023-10-20 Warnings Exact identifier application number: M020 EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20 AVOBENZONE, OCTISALATE, AND OCTOCRYLENE CLINIQUE LABORATORIES LLC 2ccf568b-b8ff-414d-b15d-0cab6a57a801 2023-10-20 Warnings Exact identifier application number: M020 CL EB MATTE MAKEUP BROAD SPECTRUM SPF 15 ZINC OXIDE AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 082b297e-d1d9-16b2-e063-6294a90a2ffd 2023-10-20 Warnings Exact identifier application number: M020 Farmasi BB Cream LIGHT to MEDIUM 02 TITANIUM DIOXIDE TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 062ffd88-2016-3c4d-e063-6394a90a5cf9 2023-10-20 Warnings Exact identifier application number: M020 Usana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30 ZINC OXIDE USANA Health Sciences, Inc. c10c188c-66e0-18ec-e053-2a95a90a5a7d 2023-10-19 Warnings Exact identifier application number: M020 SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION AVOBENZONE, HOMOSALATE, AND OCTISALATE CLINIQUE LABORATORIES LLC b0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be0 2023-10-19 Warnings Exact identifier application number: M020 CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25 TITANIUM DIOXIDE, ZINC OXIDE CLINIQUE LABORATORIES LLC 884abba1-891d-4c3c-b203-38a5a8a57756 2023-10-19 Warnings Exact identifier application number: M020 MARA Algae Zinc Sea Kale Sunscreen Serum SPF 30 ZINC OXIDE Mara Beauty LLC ba986280-eea3-b49c-e053-2995a90a3957 2023-10-19 Warnings Exact identifier application number: M020 Valmont Daily Veil. Moisturizing Face Fluid Mineral Sunscreen ZINC OXIDE Innovation Labs, Inc. 87a4b9c0-c33d-4bde-b455-dc8c33d8bb9c 2023-10-18 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Vanilla Mint Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN VANILLA MINT LIP BALM Raining Rose efe25551-777c-5336-e053-2a95a90a5c23 2023-10-18 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53675-203-00 53675020300 30 mL in 1 CONTAINER (53675-203-00) 30 ml 2022-03-08 0000-00-00 No No Current