Drugplain

COOLA BARE REPUBLIC CLEARSCREEN SPF100 30 mg/mL

Avobenzone, Homosalate, Octisalate, Octocrylene · LOTION · COOLA, LLC

No Recall History
Plain English

COOLA BARE REPUBLIC CLEARSCREEN SPF100 is a lotion containing avobenzone, homosalate, octisalate, octocrylene at 30 mg/mL, taken topical. Manufactured by COOLA, LLC.

Key Facts

Brand Name
COOLA BARE REPUBLIC CLEARSCREEN SPF100
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
NDC Code (Product)
79753-021
Manufacturer
COOLA, LLC
Strength
30 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
10/21/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

acute myeloid leukaemia2 reports
exposure to toxic agent2 reports
product contamination chemical2 reports
anaphylactic reaction1 reports
application site erythema1 reports
application site exfoliation1 reports
application site pain1 reports
application site pruritus1 reports
application site swelling1 reports
dizziness1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps prevent sunburn if used as directed with other sun protection measures (see ​Directions ​), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage & Administration

Directions apply liberally 15 minutes before sun exposure reapply: -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: -limit time in the sun, especially from 10 a.m.-2 p.m. -wear long-sleeved shirts, pants, hats, and sunglasses

Warnings

Warnings For external use only

Frequently Asked Questions

What is COOLA BARE REPUBLIC CLEARSCREEN SPF100 used for?

COOLA BARE REPUBLIC CLEARSCREEN SPF100 contains Avobenzone, Homosalate, Octisalate, Octocrylene. It is a lotion taken topical. Consult your doctor for specific uses.

Is COOLA BARE REPUBLIC CLEARSCREEN SPF100 a controlled substance?

COOLA BARE REPUBLIC CLEARSCREEN SPF100 is not classified as a controlled substance by the DEA.

What is the generic name for COOLA BARE REPUBLIC CLEARSCREEN SPF100?

The generic name for COOLA BARE REPUBLIC CLEARSCREEN SPF100 is Avobenzone, Homosalate, Octisalate, Octocrylene. There are 12 other brand versions of Avobenzone, Homosalate, Octisalate, Octocrylene.

What is the NDC code for COOLA BARE REPUBLIC CLEARSCREEN SPF100 30 mg/mL?

The NDC (National Drug Code) for COOLA BARE REPUBLIC CLEARSCREEN SPF100 30 mg/mL is 79753-021, listed by COOLA, LLC.