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 129 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Age Defying SunscreenZINC OXIDEGINAMARIE Products35837cf7-91e5-f9ec-e063-6394a90aa91e2025-12-12Exact identifier
application number: M020
Mineral Sunscreen Face plus BodyZINC OXIDEKS Esthetics, LLC390a4d8d-b47f-0d9a-e063-6394a90a9b532025-12-12Exact identifier
application number: M020
Mineral Sunscreen Tinted Zinc OxideZINC OXIDEKS Esthetics, LLC3909e657-97a5-dd3c-e063-6394a90a10eb2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS366149e2-b03c-e798-e063-6394a90a6a1d2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS3661251d-b907-8df6-e063-6294a90a1c732025-12-12Exact identifier
application number: M020
sheer tinted sunscreenTITANIUM DIOXIDE, ZINC OXIDESARA ELIZABETH SKINCARE3b177c49-ed8c-42b9-e063-6294a90a82c62025-12-12WarningsExact identifier
application number: M020
Canopy UntintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC35824cd5-0036-7886-e063-6394a90ae6782025-12-12Exact identifier
application number: M020
Canopy SPF 40 TintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC358319c5-ae35-cb3b-e063-6394a90ad77f2025-12-12Exact identifier
application number: M020
Non-Tinted Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581ab49-ef55-3743-e063-6394a90a3bd52025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly358248e6-16cf-6f9b-e063-6394a90a55d72025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly35828e76-66db-49de-e063-6294a90a2b992025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly3592fd5f-13d1-9aec-e063-6394a90abd672025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly359371f2-2407-e1a1-e063-6294a90a21652025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC397fc3c9-9d30-adcf-e063-6394a90ac7612025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC39800bf1-e01a-e1c8-e063-6294a90a53bf2025-12-12Exact 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