FDA.reportPublic FDA data

X-Treme Cream Propolis Sunscreen SPF 45

Product NDC
84378-101
11-digit product format
843780101
Labeler code
84378
Product ID
84378-101_5696e627-d1cd-95ef-e063-6394a90a2c62
Type
HUMAN OTC DRUG
Nonproprietary name
X-treme Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Epicuren Discovery
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-30
Substance
ZINC OXIDE; OCTISALATE; OCTINOXATE; OCTOCRYLENE; HOMOSALATE
Active strength
4.5; 5; 7.5; 5; 8.5 g/100g; g/100g; g/100g; g/100g; g/100g
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
X-Treme Cream Propolis Sunscreen SPF 45
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE4.5 g/100g
OCTISALATE5 g/100g
OCTINOXATE7.5 g/100g
OCTOCRYLENE5 g/100g
HOMOSALATE8.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4X49Y0596WInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b29976e-eee0-b978-e063-6294a90accd6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84378-101-74X-Treme Cream Propolis Sunscreen SPF 4574 g in 1 TUBECREAM742

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
84378-101-748437801017474 g in 1 TUBE (84378-101-74) 74 g2025-08-14NoNoCurrent