FDA.reportPublic FDA data

Oars and Alps SPF 35 Face and Scalp Mist

Product NDC
83046-368
11-digit product format
830460368
Labeler code
83046
Product ID
83046-368_ed10b246-aa9b-2b60-e053-2995a90a51d3
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Oars and Alps LLC
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-09
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 113 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC37507b14-fc01-5e27-e063-6294a90afd502025-12-16Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC375203a6-2ab8-2a80-e063-6294a90ada722025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC3751caa3-867e-5901-e063-6294a90ab6bd2025-12-16Exact identifier
application number: M020
Auset Tinted Replenishing Daily ProtectionZINC OXIDESHAYLA BOGER SKIN THERAPY LLC37da48d6-8f12-ec97-e063-6294a90a699c2025-12-16Exact identifier
application number: M020
Morning ReplenishZINC OXIDEKATHY JONES AESTHETHICS LLC37da711e-840b-2f2a-e063-6294a90ab16c2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEKATHY JONES AESTHETHICS LLC37dab729-5988-5eba-e063-6294a90ac6b72025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETory Sullivan, M.D., P.A.36241e60-f02a-50a7-e063-6394a90a63902025-12-16Exact identifier
application number: M020
Ageless All FitzZINC OXIDEA.Wall Beauty LLC37670cb1-ac75-5049-e063-6394a90a4d0a2025-12-16Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDETory Sullivan, M.D., P.A.36244b27-20e5-f370-e063-6294a90a1f6c2025-12-16Exact identifier
application number: M020
UV Defense Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e09a8-308b-b753-e063-6394a90ae9e52025-12-16Exact identifier
application number: M020
UV Defense Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e2498-7df2-f22c-e063-6294a90ac6ab2025-12-16Exact identifier
application number: M020
UV Protection Veil Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3bf5a6-33ec-0255-e063-6294a90ac96a2025-12-16WarningsExact identifier
application number: M020
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3cba2e-acc6-a2df-e063-6294a90abf712025-12-16WarningsExact identifier
application number: M020
Color Smart Tinted MineralZINC OXIDEMEGAN YORK INC.365c4623-94d5-e8b6-e063-6394a90a966a2025-12-16Exact identifier
application number: M020
Anti-Aging Tinted SunscreenZINC OXIDEKARINA SALDIVAR3bca508e-7bd0-d45d-e063-6394a90a17302025-12-16WarningsExact identifier
application number: M020
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3c757f-6581-4978-e063-6294a90a61732025-12-16WarningsExact identifier
application number: M020
Kind Restore Tinted Mineral SunscreenZINC OXIDEPOLISH BEAUTY3980810f-58b5-3a60-e063-6294a90a9c072025-12-16Exact identifier
application number: M020
Daydream Beyond ScreenZINC OXIDEULTRAVIOLET SKINCARE LLC36bfd963-d123-0d25-e063-6294a90aa8272025-12-16Exact identifier
application number: M020
Virgo SOL Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d4f43-8c57-9fcf-e063-6294a90aa9162025-12-16Exact identifier
application number: M020
Virgo SOL Non Tinted MousseTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d63a9-b9ab-9530-e063-6394a90ac8ef2025-12-16Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83046-368-648304603686450 mL in 1 BOTTLE, SPRAY (83046-368-64) 50 ml2022-11-090000-00-00NoNoCurrent