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 194 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olay Complete Hydrating with Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company3ccd2703-c410-74b7-e063-6294a90a7f882025-08-20WarningsExact identifier
application number: M020
SEYEZINC OXIDE AND TITANIUM DIOXIDE CREAMGuangzhou Seye Biomedical Technology Co., Ltd.3cce91b1-311b-4c95-e063-6294a90a2d7a2025-08-20WarningsExact identifier
application number: M020
Sun Bum Day Tripper - SPF 30 Moisturizing Sunscreen 3 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3ccfb90a-5976-4b38-e063-6294a90a123a2025-08-20WarningsExact identifier
application number: M020
Sun Bum Day Tripper - SPF 30 Sunscreen Lip Balm (Coconut) 0.15 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cd3ce69-becc-41b7-e063-6394a90a27822025-08-20WarningsExact identifier
application number: M020
Lip Therapy Soothe and Protect Lip Treatment Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEObagi Cosmeceuticals LLC4838679b-f510-440b-8670-a10c05ebed9b2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 NewZINC OXIDESun Bum, LLC3b8e1d73-b023-cfbd-e063-6294a90ae29d2025-08-19WarningsExact identifier
application number: M020
Olay Total Effects Moisturizer with Sunscreen Broad Spectrum SPF 15 Fragrance-FreeAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company8de31db2-46cf-7178-e053-2995a90a50242025-08-19WarningsExact identifier
application number: M020
Lip Balm - Variety Pack (Target) - Banana (4)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cbcae23-9b38-edaa-e063-6294a90a2e8f2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Lip Balm 30ZINC OXIDESun Bum, LLC3cbeb4ce-6d7c-387c-e063-6394a90af7902025-08-19WarningsExact identifier
application number: M020
Olay Total Effects Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company8de52cb2-b4d2-1e0d-e053-2995a90a5aca2025-08-19WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen Lip BalmZINC OXIDESun Bum, LLC3cbfba65-5702-50b5-e063-6394a90a409d2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50ZINC OXIDESun Bum, LLC324e8ddb-89d2-08ca-e063-6294a90ab6c12025-08-19WarningsExact identifier
application number: M020
Sun Bum 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b02811d-dc66-fc6f-e063-6294a90aefc82025-08-18WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b058b74-27d0-8f8a-e063-6294a90aa02c2025-08-18WarningsExact identifier
application number: M020
PLAY Mineral Stick SPF 50 with Olive Fruit ExtractZINC OXIDESupergoop LLC3ca7e1ed-7cc7-76b0-e063-6394a90ade932025-08-18WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sunscreen 6 OZZINC OXIDESun Bum, LLC3b91a7e3-ce52-6aa0-e063-6394a90a15e72025-08-18WarningsExact identifier
application number: M020
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca8742f-67cb-a25c-e063-6394a90a46382025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b154009-9c6f-eadf-e063-6394a90ae4242025-08-18WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear Sunscreen 6 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b162348-0222-490e-e063-6394a90ad4942025-08-18WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b169860-66bc-dd02-e063-6294a90a79742025-08-18WarningsExact 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