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 195 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum 30 Mineral Sunscreen Face 1.7 OZTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3b1729c5-d8ca-94c7-e063-6394a90a67a52025-08-18WarningsExact identifier
application number: M020
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca914e2-cd53-42bf-e063-6294a90a70822025-08-18WarningsExact identifier
application number: M020
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3b1a0596-b852-16be-e063-6394a90a34982025-08-18WarningsExact identifier
application number: M020
Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZOCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3b29dbfc-0b92-eb0f-e063-6294a90a16e12025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen 32 OZZINC OXIDESun Bum, LLC3b2cb7cf-7e2c-0fd2-e063-6294a90a3b172025-08-18WarningsExact identifier
application number: M020
Sun Bum Sunscreen Oil 50 5 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b2b4ba0-3f89-0a04-e063-6294a90ac1c02025-08-18WarningsExact identifier
application number: M020
Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3ca9e9d3-1c73-7bd6-e063-6394a90ad2042025-08-18WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3caaea85-0dfe-6f69-e063-6294a90a7d4a2025-08-18WarningsExact identifier
application number: M020
PLAY Lip Shield SPF 30 - MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3cab1a7d-6226-9eba-e063-6294a90a8c4d2025-08-18WarningsExact identifier
application number: M020
Sun Bum Broad Spectrum SPF 30 5 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cad0757-3155-c716-e063-6294a90ad7a92025-08-18WarningsExact identifier
application number: M020
Cica Redness Solution SunscreenZINC OXIDEMeebak Beauty, Inc15eea1eb-9468-4611-915d-e43112c4a4f52025-08-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE/OCTOCRYLENEEdgewell Personal Care Brands LLC3c936ed0-ab7a-ccec-e063-6294a90afd932025-08-17WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE OCTOCRYLENE OXYBENZONEEdgewell Personal Care Brands LLC0f772b91-e67b-46cf-e054-00144ff8d46c2025-08-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, OCTOCRYLENE, OXYBENZONEEdgewellPersonal Care Brands LLC353353b9-54f8-4300-9632-7615de3940762025-08-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC0c6aeadb-f61d-29e3-e063-6294a90a74732025-08-17WarningsExact identifier
application number: M020
MOISTURE SURGE SPFAVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCec921e21-db68-db77-e053-2a95a90a57812025-08-15WarningsExact identifier
application number: M020
Olay Invisible Sunscreen Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company3c69f096-1575-309b-e063-6394a90a72292025-08-15WarningsExact identifier
application number: M020
MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCea4d564f-ac64-abac-e053-2a95a90a8abb2025-08-15WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sunset Cove CardedHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac67c26-d56e-32a9-e063-6294a90a10482025-08-15WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDESun Bum, LLC3aa13423-045a-7227-e063-6294a90ae49b2025-08-15WarningsExact 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