FDA.reportPublic FDA data

SUMMER GELEE SPF-4

Manufacturer
SUMMER GELEE LLC
Effective date
2024-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:05

Label at a glance#

ProductSUMMER GELEE SPF-4
Active ingredientHOMOSALATE, OCTISALATE
Label structure7 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.  If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours.  Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures:  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun prote...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 2.00%, Octisalate 2.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

  • Higher SPF gives more sunburn protection. 
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure and as needed.

  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours. 
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10am-2pm.
  • Wear long-sleeved shirts, pants, hats, & sunglasses.

Other Information:

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Cinnamomum Cassia Oil, Hydrogenated Vegetable Oil, Iron Oxides (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Tocopheryl Acetate (Vitamin E), D&C Red #17.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84281-476-00SUMMER GELEE SPF-492.26 mL in 1 TUBEGEL92.261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84281-476SUMMER GELEE SPF-4 (HOMOSALATE, OCTISALATE) GEL [SUMMER GELEE LLC]1Current NDC, 1 package rows20240507_c9ec81ad-0478-4026-bc6c-5582eb012b8d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84281-47684281-476-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHINESE CINNAMON OILA4WO0626T5IACT
FERRIC OXIDE RED1K09F3G675IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
D&C RED NO. 17ND733RX3JNIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUMMER GELEE SPF-4HOMOSALATE, OCTISALATESUMMER GELEE LLCc9ec81ad-0478-4026-bc6c-5582eb012b8d2024-04-27WarningsExact identifier
ndc (package): 84281-476-00
ndc (product): 84281-476
ndc11 (package): 84281047600
spl id: 171b4cde-2e02-0bb4-e063-6394a90a9deb
spl set id: c9ec81ad-0478-4026-bc6c-5582eb012b8d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.