FDA.reportPublic FDA data

Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick

Product NDC
53675-203
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
IngredientStrength
ZINC OXIDE200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3201cc8b-5fee-4f3b-a826-e349786d1b32Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-203-00Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick30 mL in 1 CONTAINERSTICK302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-203SPORT BROAD SPECTRUM SPF50 WATER RESISTANT 80 MINUTES MINERAL SUNSCREEN UVA UVB PROTECTION STICK (ZINC OXIDE) STICK [ARUBA ALOE BALM NV]2Current NDC, Legacy NDC, 1 package rows20231108_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 316 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skinAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1c83726b-f8ff-48d5-bf30-bc75e3fb149d2023-12-29WarningsExact identifier
application number: M020
LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20OCTINOXATEL'Oreal USA Products Inccf39375c-de44-47de-bf15-fce4dfad8c742023-12-29WarningsExact identifier
application number: M020
Loreal Paris Age Perfect Radiant Serum foundation SPF 50HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06a94c28-bfb7-4842-a463-459205477cd82023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PEACHES N SOLZINC OXIDE SUNSCREENBentley Laboratories, LLCe7c9c914-9972-4b55-a49d-cbc8ce0756472023-12-29WarningsExact identifier
application number: M020
LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25AVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8840da10-63cb-47ea-ad46-1ae6df1639e82023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PINK SUNRISEZINC OXIDE SUNSCREENBentley Laboratories, LLC289fb410-7884-4bc4-a25b-963de1cc3a702023-12-29WarningsExact identifier
application number: M020
LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 SunscreenOCTINOXATEL'Oreal USA Products Inc82a6fbba-f0d4-475f-9ba7-615118eed70d2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Youth Code Dark Spot Corrector Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inca32f7458-d7ad-47e5-804d-de260c0726de2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc917f6775-8f48-4b7e-9f67-253bc0c6d59e2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Revitalift Triple Power Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc9b6adfab-cafa-4343-9c96-e187fe0986db2023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURSTZINC OXIDE SUNSCREENBentley Laboratories, LLC4785585e-b623-4125-9867-8097694c7b582023-12-29WarningsExact identifier
application number: M020
LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17OCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inca31dacaa-738d-4da8-95b2-4d737c5266832023-12-29WarningsExact identifier
application number: M020
LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 25 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8e294a61-97e2-4df8-8a59-7cec12c6f0162023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30- SUNSET ROSEZINC OXIDE SUNSCREENBentley Laboratories, LLCe351dff2-4237-4458-a947-b894e7b670a32023-12-29WarningsExact identifier
application number: M020
LOreal Paris Wrinkle Expert Age Defense 55 Plus Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incfa0b25a9-648a-4c7e-95c0-b7cb3dd525dd2023-12-29WarningsExact identifier
application number: M020
Radiant Shield Broad spectrum SPF 40 Tinted Mineral SunscreenZINC OXIDECosMedical Technologies, LLCef75cd9d-eaf5-430e-9a80-30c50da921ff2023-12-28WarningsExact identifier
application number: M020
SkinCeuticals Daily Brightening UV Defense Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc76e03a17-947a-492a-9e64-d3f7762de8232023-12-28WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Hydra Daily Invisible Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inccc61299b-5088-4cef-b90e-f5de67e46b252023-12-28WarningsExact identifier
application number: M020
Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incea0609be-eaa9-4b63-9f07-e2cd974e01ba2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incb3a37055-b58f-4c42-963b-01c1136f692d2023-12-28WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-203-005367502030030 mL in 1 CONTAINER (53675-203-00) 30 ml2022-03-080000-00-00NoNoCurrent