FDA.reportPublic FDA data

Walgreens Broad Spectrum SPF 50 Body Oil Sunscreen

Product NDC
0363-0366
11-digit product format
003630366
Labeler code
0363
Product ID
0363-0366_2410e0fc-065c-b86a-e063-6294a90acbd2
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
WALGREEN COMPANY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-19
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
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
Walgreens Broad Spectrum SPF 50 Body Oil Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE150 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2410df0a-db52-0769-e063-6394a90a52f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0366-21Walgreens Broad Spectrum SPF 50 Body Oil Sunscreen148 mL in 1 BOTTLE, SPRAYSPRAY1481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0366WALGREENS BROAD SPECTRUM SPF 50 BODY OIL SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [WALGREEN COMPANY]1Current NDC, 1 package rows20241011_2410df0a-db52-0769-e063-6394a90a52f3.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
0363-0366-2100363036621148 mL in 1 BOTTLE, SPRAY (0363-0366-21) 148 ml2024-09-19NoNoCurrent