FDA.reportPublic FDA data

Poth Clear Gel Sunscreen SPF 50

Product NDC
87669-963
11-digit product format
876690963
Labeler code
87669
Product ID
87669-963_5123e244-ac63-ebf1-e063-6394a90a14e3
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
GEL
Route
TOPICAL
Labeler
Poth LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-14
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 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
Poth Clear Gel Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 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
1b0b6716-f4e1-4a3b-9f06-1c95f1f8a17aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87669-963-00Poth Clear Gel Sunscreen SPF 5059 mL in 1 BOTTLEGEL591
87669-963-00Poth Clear Gel Sunscreen SPF 501 in 1 BOXGEL11

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 38 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC507560fe-c7ad-329a-e063-6394a90a039a2026-04-27WarningsExact identifier
application number: M020
SoloVeganHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEYES SALES INC.435748e6-c39a-efee-e063-6294a90ad0e52026-04-27WarningsExact identifier
application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC50764f40-7881-81a3-e063-6294a90ad1cf2026-04-27WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC495bc176-b292-448f-a5a6-00de2e475e542026-04-27WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45bd7bd-a802-33e4-e053-2a95a90a61a72026-04-23WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERPML NYC, LLC1c2e9b0d-ba0e-1767-e063-6394a90a756c2026-04-23WarningsExact identifier
application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATEBeauty Solutions, Ltd.76e2ed34-c643-402b-9c9d-04eac789d3c22026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50ZINC OXIDEKenvue Brands LLC4fe1d3c6-7748-d966-e063-6394a90a97ff2026-04-22WarningsExact identifier
application number: M020
OVERLAPS ECTOIN MOIST SUNAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOverlaps Corp.4c3ed60b-e515-8ff0-e063-6294a90a86df2026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacestickZINC OXIDESunny Day Creations50101b55-793e-dbe4-e063-6394a90a61992026-04-22WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%S&C Hampton Sun LLCe6103de6-1d80-46fd-b9d4-893f60941def2026-04-22WarningsExact identifier
application number: M020
PhotoAge GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMACROMOTION, INC.50164bd8-469d-9ec1-e063-6294a90a543d2026-04-22WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun StickAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD49947114-5137-dc45-e063-6394a90ad9d02026-04-22WarningsExact identifier
application number: M020
Sky and Sol Intense Healing Lip JellyNON-NANO ZINC OXIDEDelta Ecommerce LLC2ddaa215-7433-c8fa-e063-6394a90a43162026-04-22WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLC0445ee5f-45a8-4fd5-ae4d-62f66e6f0be82026-04-21WarningsExact identifier
application number: M020
BLDG Active Skin Repair Face and Body Performance SunscreenZINC OXIDEInnovacyn, Inc.70cb98cf-739b-4d46-b45a-535ff0a4531c2026-04-21WarningsExact identifier
application number: M020
Freaks of Nature Mineral SunscreenZINC OXIDE MINERAL SUNSCREENEmpack Spraytech Inc.4ffdb1c6-b2c6-628f-e063-6394a90a27692026-04-21WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Water Sun CreamAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD5004126b-0a9c-21fb-e063-6294a90a52372026-04-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87669-963-00876690963001 BOTTLE in 1 BOX (87669-963-00) / 59 mL in 1 BOTTLE1 bottle2024-04-14NoNoCurrent