FDA.reportPublic FDA data

SOLMED SUNSCREEN FACE SHIELD

Product NDC
85446-045
11-digit product format
854460045
Labeler code
85446
Product ID
85446-045_31b07743-fe92-62c4-e063-6294a90a6fc7
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Ethylhexyl Salicylate, Homosalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
FEELFREE LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-31
Substance
HOMOSALATE; ETHYLHEXYL SALICYLATE; AVOBENZONE; OCTOCRYLENE
Active strength
5; 2.5; 1.5; 5 g/50g; g/50g; g/50g; g/50g
NDC exclude flag
No
Listing certified through
2026-12-31
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
SOLMED SUNSCREEN FACE SHIELD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE5 g/50g
ETHYLHEXYL SALICYLATE2.5 g/50g
AVOBENZONE1.5 g/50g
OCTOCRYLENE5 g/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal 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
31b077cc-32b9-78e6-e063-6394a90a155aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85446-045-01SOLMED SUNSCREEN FACE SHIELD50 g in 1 TUBECREAM501
85446-045-02SOLMED SUNSCREEN FACE SHIELD1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85446-045SOLMED SUNSCREEN FACE SHIELD (AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE) CREAM [FEELFREE LLC]1Current NDC, 2 package rows20250403_31b077cc-32b9-78e6-e063-6394a90a155a.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 322 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
application number: M020
BEAST SPIT and POLISH FACE SPF-20OCTOCRYLENE, OCTISALATE, AVOBENZONESmall Batch Beauty, LLC27e5244b-4b69-4dec-9dd5-ba8b71b171b22023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLCbd60cf89-e0e9-48ad-b174-1ecf72557d9c2023-11-11WarningsExact identifier
application number: M020
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLC6d6b5b2a-210a-4606-9cdb-f6eec10f37e82023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Baby Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCac66ad82-a01f-4e44-92a7-b5ab5bd309222023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Daily Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLC1745dc35-648e-4315-a285-c99ebeef4f6a2023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Face Factor Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCedc2c1e7-e1a8-4b49-96df-8a94eb6a242a2023-11-11WarningsExact identifier
application number: M020
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF 50 SPORTOCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.f01516bf-8aed-4402-a3f9-ef11c54d46b32023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF-30OCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.4df55434-fb9a-442d-82cf-16a4957f0a2a2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-30ZINC OXIDEProject Reef LLCb7de9ec2-6db1-4c89-b734-15c4bd5c32512023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO Cooling Mist SPF-60 SportHOMOSALATE, OCTISALATE, ZINC OXIDEThe Seaweed Bath Co.98ccbb70-6e1a-4e92-a095-cbc4be12fcbf2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
application number: M020
YOUTH CORRIDOR Soothe and Defend SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEYouth Corridor5c0873ff-8e76-48de-919d-f69794c4bd372023-11-11WarningsExact identifier
application number: M020
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDEZITSTICKA, Inc32164318-7a7e-40b2-99da-8246c99fdbd32023-11-11WarningsExact identifier
application number: M020
SUNNY Q Broad Spectrum SPF-30ZINC OXIDESunny Q Sunscreen LLC593870fa-425c-401c-ac26-f63f4ce0298f2023-11-11WarningsExact identifier
application number: M020
BRICKELL Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC44806b83-9220-4d34-806d-20cf0a47186e2023-11-11WarningsExact identifier
application number: M020
BRICKELL Element Defense Moisturizer SPF-45OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC94be278a-3773-469b-8e40-3242d1072a3d2023-11-11WarningsExact identifier
application number: M020
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEThirty7 LLC6ff00b6e-1cc7-4cc4-842b-4e379f75e4542023-11-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85446-045-018544600450150 g in 1 TUBE50 gHistorical
85446-045-02854460045021 TUBE in 1 BOX (85446-045-02) / 50 g in 1 TUBE (85446-045-01) 1 tube2025-03-31NoNoCurrent