Drugplain

SUMMER GELEE SPF-30 100 mg/mL

HOMOSALATE, OCTISALATE, OCTOCRYLENE · GEL · SUMMER GELEE LLC

No Recall History
Plain English

SUMMER GELEE SPF-30 is a gel containing homosalate, octisalate, octocrylene at 100 mg/mL, taken topical. Manufactured by SUMMER GELEE LLC.

Key Facts

Brand Name
SUMMER GELEE SPF-30
Generic Name
HOMOSALATE, OCTISALATE, OCTOCRYLENE
NDC Code (Product)
84281-477
Manufacturer
SUMMER GELEE LLC
Strength
100 mg/mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
05/06/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

Directions: 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.

Warnings

Warnings: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

Frequently Asked Questions

What is SUMMER GELEE SPF-30 used for?

SUMMER GELEE SPF-30 contains HOMOSALATE, OCTISALATE, OCTOCRYLENE. It is a gel taken topical. Consult your doctor for specific uses.

Is SUMMER GELEE SPF-30 a controlled substance?

SUMMER GELEE SPF-30 is not classified as a controlled substance by the DEA.

What is the generic name for SUMMER GELEE SPF-30?

The generic name for SUMMER GELEE SPF-30 is HOMOSALATE, OCTISALATE, OCTOCRYLENE. There are 12 other brand versions of HOMOSALATE, OCTISALATE, OCTOCRYLENE.

What is the NDC code for SUMMER GELEE SPF-30 100 mg/mL?

The NDC (National Drug Code) for SUMMER GELEE SPF-30 100 mg/mL is 84281-477, listed by SUMMER GELEE LLC.