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 261 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Lip Cream SPF 15ZINC OXIDECOSMAX USA, CORPORATION29227121-e579-8eea-e063-6394a90a302f2024-12-13WarningsExact identifier
application number: M020
BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONEBobbi Brown Professional Cosmetics Inc.03372376-ef03-943d-e063-6394a90a52ee2024-12-13WarningsExact identifier
application number: M020
WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.fbd04b66-738b-2762-e053-6394a90a8b722024-12-13WarningsExact identifier
application number: M020
Mentholatum Natural Ice CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company33f43f14-8e0b-41b1-8ad0-5723d2a7bf192024-12-13WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 8 SunscreenZINC OXIDEAbsolutely Naturala26217cf-22ab-4c39-980a-b73467e16b912024-12-13WarningsExact identifier
application number: M020
Calming Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienced681cdb5-307e-4a2a-8e1d-2b29131d48d02024-12-13WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Natural8084a3ee-fe31-4cb4-8d3c-e4035d29e5612024-12-13WarningsExact identifier
application number: M020
Mineral Corrector Palette SPF 20 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescienceab70122f-bd68-4781-841f-dc83284e14032024-12-13WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC0a0654cc-ad47-2167-e063-6294a90a52f42024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEBabo Botanicals, Inc.f8adda52-e909-1905-e053-6294a90a3c782024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.f8b1ea3a-d62e-e00d-e053-6394a90a56892024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50ZINC OXIDEBabo Botanicals, Inc.f8b272f6-8726-de1d-e053-6294a90a7b1e2024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Super Shield Sport Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.e3ca7840-4882-d605-e053-2a95a90af6ab2024-12-12WarningsExact identifier
application number: M020
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural GlowMINERAL SUNSCREENBabo Botanicals, Inc.ab39d9f0-d869-6f33-e053-2995a90a08d42024-12-12WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs88dedeb8-963f-5849-e053-2995a90aab722024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Extra Light TintZINC OXIDEMV Advanced7834c649-5f6d-b005-e053-2a91aa0a10842024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Light TintZINC OXIDEMV Advanced783649af-d746-84a3-e053-2991aa0a9e3d2024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Medium TintZINC OXIDEMV Advanced783649af-d768-84a3-e053-2991aa0a9e3d2024-12-12WarningsExact identifier
application number: M020
Babo SPF 30 Clear Zinc Fragrance Free SportMINERAL SUNSCREENBabo Botanicals, Inc.b1a9f76d-0cef-29da-e053-2995a90af34c2024-12-12WarningsExact identifier
application number: M020
Babo Baby Face Mineral SunscreenMINERAL SUNSCREENBabo Botanicals, Inc.b131664d-1ad2-0a2f-e053-2995a90acbda2024-12-12WarningsExact 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