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 340 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 4c40047b-01d6-4221-a044-9f884519bdd5 2023-10-05 Warnings Exact identifier application number: M020 CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY AVOBENZONE AND OCTISALATE CLINIQUE LABORATORIES LLC 9c9a0fa4-b440-4d7f-805e-d997e120024d 2023-10-05 Warnings Exact identifier application number: M020 EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE CLINIQUE LABORATORIES LLC 756cb656-2f79-4e7f-b4b3-18d6e8930921 2023-10-05 Warnings Exact identifier application number: M020 bareMinerals ORIGINAL Liquid Mineral Foundation Broad Spectrum SPF 20 Sunscreen FAIR 01 TITANIUM DIOXIDE Orveon Global US, LLC f083af9e-e235-5f03-e053-2a95a90a5325 2023-10-04 Warnings Exact identifier application number: M020 Fair Foundation SPF 15 ZINC OXIDE, TITANIUM DIOXIDE Orveon Global US, LLC 491a5768-1aad-458e-b4d6-72ea085d1d9f 2023-10-04 Warnings Exact identifier application number: M020 BAREMINERALS SPF 20 CORRECTING CONCEALER Dark 2 TITANIUM DIOXIDE Orveon Global US LLC 6845acee-5a3f-4c8d-9386-8823b30373f3 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01 TITANIUM DIOXIDE Orveon Global US, LLC 798934af-f011-4a95-bdb6-b577154713c4 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Complexion Rescue Brightening Concealer SPF 25 Deep Mahogany TITANIUM DIOXIDE Orveon Global US LLC f03b4fa3-4da9-5e44-e053-2a95a90af344 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 Cashew 3.5 TITANIUM DIOXIDE Orveon Global US LLC 2de76f3c-b438-47ca-84e5-e871e9d995a4 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Original Foundation Broad Spectrum SPF 15 Fair Ivory TITANIUM DIOXIDE Orveon Global US LLC 15c92bce-75f4-40e3-ae28-9bcbc241c8e9 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft Radiance TITANIUM DIOXIDE AND ZINC OXIDE Orveon Global US LLC 0c2db44d-8604-4883-ab01-f14bc441e4e4 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12 TITANIUM DIOXIDE AND ZINC OXIDE Orveon Global US LLC 3c35fd13-1a4b-4acf-ada4-16ee2e52dd94 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 Medium TITANIUM DIOXIDE AND ZINC OXIDE Orveon Global US LLC 3cc5b952-4619-4395-97c0-5b68efa9af6d 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Orveon Global US LLC 29c25bc3-902a-41af-996a-8c7e8a4bf574 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03 TITANIUM DIOXIDE Orveon Global US LLC b2909888-5a98-4894-a895-230aa53f64d9 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19 TITANIUM DIOXIDE AND ZINC OXIDE Orveon Global US LLC a5888955-f381-4209-9589-bd2e79a84f59 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08 TITANIUM DIOXIDE AND ZINC OXIDE Orveon Global US LLC ad15bdee-67e6-4281-8144-e84b7c478a34 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18 TITANIUM DIOXIDE AND ZINC OXIDE Orveon Global US LLC aa4d7945-6cc9-4f20-b588-a5588e57d30a 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Tan 20 TITANIUM DIOXIDE AND ZINC OXIDE Orveon Global US LLC 2f8b6c57-dcae-408e-898d-d5630deeb090 2023-10-04 Warnings Exact identifier application number: M020 bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Dark 24 ZINC OXIDE Orveon Global US LLC beaf1ff7-4942-4ba5-ba25-3287cc409e93 2023-10-04 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