FDA.reportPublic FDA data

Arizona Sun Sunscreen SPF15

Product NDC
61973-101
11-digit product format
619730101
Labeler code
61973
Product ID
61973-101_4f0c7928-aeae-77cc-e063-6394a90a0c43
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
Arizona Sun
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-05
Substance
OCTISALATE; AVOBENZONE; OCTINOXATE; OXYBENZONE
Active strength
30; 20; 75; 30 mg/g; mg/g; mg/g; mg/g
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
Arizona Sun Sunscreen SPF15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE30 mg/g
AVOBENZONE20 mg/g
OCTINOXATE75 mg/g
OXYBENZONE30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10a600aa-4faa-47fc-e063-6294a90ac4efAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61973-101-01Arizona Sun Sunscreen SPF1530 g in 1 BOTTLELOTION302
61973-101-03Arizona Sun Sunscreen SPF1590 g in 1 BOTTLELOTION902
61973-101-04Arizona Sun Sunscreen SPF15120 g in 1 BOTTLELOTION1202
61973-101-08Arizona Sun Sunscreen SPF15946 g in 1 BOTTLELOTION9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61973-101ARIZONA SUN SUNSCREEN SPF15 (SUNSCREEN) LOTION [ARIZONA SUN PRODUCTS]1Current NDC, 1 package rows20240214_10cd4a29-0139-9435-e063-6394a90a51a4.zip
61973-101ARIZONA SUN SUNSCREEN SPF15 (SUNSCREEN) LOTION [ARIZONA SUN PRODUCTS]1Current NDC, 1 package rows20240216_10cf56d0-ddf9-7cf1-e063-6294a90a99c4.zip
61973-101ARIZONA SUN SUNSCREEN SPF15 (SUNSCREEN) LOTION [ARIZONA SUN PRODUCTS]1Current NDC, 1 package rows20240209_10d02ba4-6701-865a-e063-6394a90ac911.zip
61973-101ARIZONA SUN SUNSCREEN SPF15 (SUNSCREEN) LOTION [ARIZONA SUN]1Current NDC, 1 package rows20240216_10a600aa-4faa-47fc-e063-6294a90ac4ef.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 305 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrator Plus SPF 30BROAD SPECTRUMCP Skin Health Group, Inc.b6c0db82-9fba-6216-e053-2a95a90a75602024-02-14WarningsExact identifier
application number: M020
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/OOCTINOXATE, TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10f7ec01-541b-a15a-e063-6294a90aa9df2024-02-09WarningsExact identifier
application number: M020
SunscreenHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONESafetec of America, Inc.754186c8-3c88-40a0-a4e3-35e3ea9d1b4c2024-02-08WarningsExact identifier
application number: M020
MIAMI BEACH BUM SPF-50 Blocked SunscreenZINC OXIDEMIAMI BEACH BUM2cf40d87-626b-4309-8f13-fd980161c62f2024-02-07WarningsExact identifier
application number: M020
Equate Sunscreen for All Skin Tones SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWAL-MART INC.1062060a-a5c7-1805-e063-6294a90ab8022024-02-02WarningsExact identifier
application number: M020
Equate Kids Sunscreen Broad Spectrum SPF 50 EquateAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWAL-MART INC.10631036-0fa6-b3ee-e063-6294a90af7aa2024-02-02WarningsExact identifier
application number: M020
Death Tan SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEDerma Care Research Labs, LLC106ab5e2-e134-b81d-e063-6294a90a5bca2024-02-02WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden HourTITANIUM DIOXIDECOOLA, LLCedfda0f5-0f72-5cc7-e053-2a95a90ae38d2024-02-02WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Summer CrushZINC OXIDECOOLA, LLCedc6754e-dabb-5bff-e053-2a95a90a73902024-02-02WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Skinny DipZINC OXIDECOOLA, LLCee01f936-81a9-a54d-e053-2a95a90a52272024-02-02WarningsExact identifier
application number: M020
toty Solaria MineralTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe9d590d8-e71a-0715-e053-2a95a90a5acf2024-02-01WarningsExact identifier
application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50ZINC OXIDELG H&H Co., Ltd.10d343c8-f0c1-6b90-e063-6294a90a24ba2024-02-01WarningsExact identifier
application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50ZINC OXIDEfmg Co.Ltd10d401af-fd92-d82a-e063-6294a90a9f7f2024-02-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc18f05adb-43a8-47e5-bc5a-fbf3209d0a442024-01-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production03593e3c-c98a-43af-82bc-10331e23342c2024-01-31WarningsExact identifier
application number: M020
ATOMY SUNHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANEATOMY CO., LTD.bdf0a11d-3563-4b09-a430-f031709cb3f32024-01-30WarningsExact identifier
application number: M020
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
application number: M020
EltaMD UV Lip Balm SPF31ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health, Inc0ec70f0a-cda4-4953-b056-e1e6e9921e5b2024-01-25WarningsExact identifier
application number: M020
BBW SPF 35 Natural Lip BalmBBW SPF 35 NATURAL LIP BALMAutumn Harp0f8b024c-c481-951b-e063-6394a90ac63c2024-01-22WarningsExact identifier
application number: M020
Bath and Body Works SPF 35 Natural Lip BalmBATH AND BODY WORKS SPF 35 NATURAL LIP BALMBath and Body Works, Inc.0f8dab80-c84f-ffbd-e063-6294a90a317e2024-01-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61973-101-016197301010130 g in 1 BOTTLE (61973-101-01) 30 g2024-02-07NoNoCurrent
61973-101-036197301010390 g in 1 BOTTLE (61973-101-03) 90 g2024-02-07NoNoCurrent
61973-101-0461973010104120 g in 1 BOTTLE (61973-101-04) 120 g2024-02-05NoNoCurrent
61973-101-0861973010108946 g in 1 BOTTLE (61973-101-08) 946 g2024-02-07NoNoCurrent