FDA.reportPublic FDA data

SUMMER GELEE SPF-30

Product NDC
84281-477
11-digit product format
842810477
Labeler code
84281
Product ID
84281-477_171b43a9-7f61-f8ff-e063-6294a90ab5fb
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
GEL
Route
TOPICAL
Labeler
SUMMER GELEE LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-06
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
100; 50; 50 mg/mL; mg/mL; mg/mL
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
SUMMER GELEE SPF-30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
bc85db65-2acc-4b39-9189-f8916c487b61Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84281-477-00SUMMER GELEE SPF-3092.26 mL in 1 TUBEGEL92.261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84281-477SUMMER GELEE SPF-30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [SUMMER GELEE LLC]1Current NDC, 1 package rows20240507_bc85db65-2acc-4b39-9189-f8916c487b61.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 218 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5aab267-b33b-a40d-e053-2a95a90a9d792025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5beb9cd-aa3b-2b37-e053-2995a90a84092025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5bdc0c8-af2c-1096-e053-2995a90a89172025-04-01WarningsExact identifier
application number: M020
Mesoestetic Mesoprotech Melan 130 Pigment ControlAVOBENZONE, HOMOSALATE, OCTOCRYLENEMESOESTETIC PHARMA GROUP SL3b50e874-9665-4df4-8b3a-fc932c29f3f62025-04-01WarningsExact identifier
application number: M020
AVON BEYOND GLOW SUN MOISTURIZERAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30c83f4f-9de0-6fbf-e063-6394a90af1ae2025-04-01WarningsExact identifier
application number: M020
EltaMD UV DailyOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6dde7055-5f77-4a7f-a182-c03e1f30bfaa2025-03-31WarningsExact identifier
application number: M020
natural lip balm SPF15( chocolate sundae) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.319e8e26-b29d-4627-e063-6294a90acfba2025-03-31WarningsExact identifier
application number: M020
Face Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEVege Labs31aad575-a5d1-42b0-e063-6294a90a6c812025-03-31WarningsExact identifier
application number: M020
SOLMED SUNSCREEN FACE SHIELDAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEFEELFREE LLC31b077cc-32b9-78e6-e063-6394a90a155a2025-03-31WarningsExact identifier
application number: M020
TATCHA THE SILK SUNSCREENZINC OXIDETATCHA INC.7799042a-d2de-480e-a8a3-827b3dc279072025-03-31WarningsExact identifier
application number: M020
Cotz Sensitive SPF 40 SunscreenZINC OXIDEFallien Cosmeceuticals, LTD.885a674b-3457-4dfe-a801-529094b004992025-03-31WarningsExact identifier
application number: M020
EltaMD UV Daily TintedOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Incad8aafdf-f3bc-497f-9792-20c2911c12d02025-03-31WarningsExact identifier
application number: M020
EltaMD UV Clear Tinted SPF46ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.1ac59ef1-113e-4ad1-90c3-38353bc7e1ec2025-03-31WarningsExact identifier
application number: M020
lip balm SPF15( CB222) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316416d0-52b5-6f2f-e063-6294a90a9bc12025-03-28WarningsExact identifier
application number: M020
lip balm SPF15( CB400) 01OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316463e0-dc1f-e2ae-e063-6394a90a0c3c2025-03-28WarningsExact identifier
application number: M020
Sunscreen Stick SPF30( CB400) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316498d9-32fe-f884-e063-6394a90a43072025-03-28WarningsExact identifier
application number: M020
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
application number: M020
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
application number: M020
TRADER JOES SHIMMER GLOW SUNSCREEN SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETrader Joe's Company316c7793-5937-9ce4-e063-6294a90ae0a12025-03-28WarningsExact identifier
application number: M020
CeraVe AM Facial Moisturizing Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Incdc85cff3-df18-4bb7-8d71-bb0878959fe22025-03-28WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84281-477-008428104770092.26 mL in 1 TUBE (84281-477-00) 92.26 ml2024-05-06NoNoCurrent