FDA.reportPublic FDA data

Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen

Product NDC
83046-369
11-digit product format
830460369
Labeler code
83046
Product ID
83046-369_29b7102e-b3b4-67e3-e063-6294a90a7ded
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
Oars and Alps LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-01
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
15.7; 3.4 g/100mL; g/100mL
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
Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15.7 g/100mL
TITANIUM DIOXIDE3.4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3971b85-a13e-4195-e053-2995a90a73cbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83046-369-13Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen177 mL in 1 CANSPRAY1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83046-369OARS AND ALPS SPF 50 100% MINERAL ANTIOXIDANT SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) SPRAY [OARS AND ALPS LLC]2Current NDC, 1 package rows20241222_f3971b85-a13e-4195-e053-2995a90a73cb.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 291 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Golden Glow Tanning Oil SPF-15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC748a9933-02a3-48c1-8636-8f0468f66a132024-07-17WarningsExact identifier
application number: M020
Tan De Soleil Orange Tanning Balm SPF 6HOMOSALATE, OCTISALATETANNING CLUB, LLC5343f359-6074-467c-99bb-f08a7ca2df412024-07-17WarningsExact identifier
application number: M020
Tanning Club Tanning SPF-8AVOBENZONE, OCTOCRYLENETANNING CLUB, LLCbbf9d61e-f2e6-4fde-baad-c412091c60b62024-07-17WarningsExact identifier
application number: M020
Mackenzies SPF 40 Ocean Safe SunscreenZINC OXIDENaturally Uncommon LLC1c314b70-45a7-1bd1-e063-6294a90a0d6b2024-07-17WarningsExact identifier
application number: M020
Bitchstix Eucalyptus Mint SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d764eb8-a0a7-d034-e063-6394a90aef242024-07-17WarningsExact identifier
application number: M020
Bitchstix Acai Berry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d765c28-f9da-15b6-e063-6394a90a057f2024-07-17WarningsExact identifier
application number: M020
Bitchstix Banana Kiwi SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e972-4fc1-9438-e063-6294a90a58452024-07-17WarningsExact identifier
application number: M020
Bitchstix Pineapple Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7699f4-3088-9436-e063-6294a90ab8522024-07-17WarningsExact identifier
application number: M020
Bitchstix Black Cherry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76824a-eac4-2d1f-e063-6294a90a8e662024-07-17WarningsExact identifier
application number: M020
Bitchstix Classic Coconut SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76aed7-308b-5cc5-e063-6394a90a45432024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Watermelon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e9b7-95af-6015-e063-6294a90a6f192024-07-17WarningsExact identifier
application number: M020
Bitchstix Vanilla Creme SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7713a9-de97-f0ff-e063-6294a90a80032024-07-17WarningsExact identifier
application number: M020
Bitchstix Grapefruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7723c7-984a-a789-e063-6394a90abdc42024-07-17WarningsExact identifier
application number: M020
Bitchstix Matcha and Aloe SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d771406-7c59-6052-e063-6394a90a01e62024-07-17WarningsExact identifier
application number: M020
Bitchstix Lemon Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d770a10-a9fa-94c4-e063-6294a90a137a2024-07-17WarningsExact identifier
application number: M020
Bitchstix Mango SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77866e-64f2-86d6-e063-6394a90a12922024-07-17WarningsExact identifier
application number: M020
Bitchstix Peachy Peach SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77c31e-c606-74b7-e063-6294a90a2cee2024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Lemon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77d785-56eb-e865-e063-6394a90acd012024-07-17WarningsExact identifier
application number: M020
Bitchstix Pomegranate SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffd-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix Strawberry Dragon Fruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77f460-e7be-30fe-e063-6394a90a8f1e2024-07-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83046-369-1383046036913177 mL in 1 CAN (83046-369-13) 177 ml2022-12-01NoNoCurrent