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 202 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skinuva Scar plusZINC OXIDEMD Medical Designs, Inc.5fcad8c3-a268-4966-b0a9-6cd2c7afd3b72025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 29 Active with DNArescueOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC99fb90ca-6527-459b-8af2-627ea9abe11b2025-07-25WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa93f52-ec01-01c2-e063-6294a90a93472025-07-24WarningsExact identifier
application number: M020
Mineral Suscreen SPF 30ZINC OXIDE 19.0%Vivant Pharmaceuticals, LLC3aadb658-d12d-ae8d-e063-6394a90a64962025-07-24WarningsExact identifier
application number: M020
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
application number: M020
Leg and Body Makeup Broad Spectrum SPF 25OCTISALATE 3.2% OCTOCRYLENE 6%Baxter of California, LLC14adc826-6e9d-382a-e063-6294a90a5d792025-07-24WarningsExact identifier
application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20AVOBENZENE, OCTINOXATE, OCTOCRYLENETIEGE HANLEY, Inc22086cd8-2126-120e-e063-6394a90a561e2025-07-24WarningsExact identifier
application number: M020
Tulip Dew SHIELD GLOWZINC OXIDEBloomeffects, Inc.150f9660-48ec-a189-e063-6294a90a6d492025-07-23WarningsExact identifier
application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3a9f94eb-98b7-5a20-e063-6394a90a173b2025-07-23WarningsExact identifier
application number: M020
Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a9fc050-f74f-a431-e063-6294a90ad4c22025-07-23WarningsExact identifier
application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3aa0799b-0790-2476-e063-6294a90a8bcc2025-07-23WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa3c442-26a6-0ab0-e063-6294a90a93a52025-07-23WarningsExact identifier
application number: M020
Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89106d-dbf0-e6ea-e063-6294a90a60f32025-07-22WarningsExact identifier
application number: M020
Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a898964-b4aa-e86d-e063-6394a90a34c62025-07-22WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal System KitAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3512c120-b8ba-ba59-e063-6394a90ac1e22025-07-22WarningsExact identifier
application number: M020
Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a89d736-efef-088e-e063-6394a90a5e622025-07-22WarningsExact identifier
application number: M020
Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8a093b-cc9c-26fc-e063-6394a90a20282025-07-22WarningsExact identifier
application number: M020
Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8a87d6-ef86-60c2-e063-6394a90a07062025-07-22WarningsExact identifier
application number: M020
Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8b773c-f456-836a-e063-6294a90a0d462025-07-22WarningsExact identifier
application number: M020
Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8bc90d-350f-98c8-e063-6294a90abd9c2025-07-22WarningsExact 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