COOLA Refreshing Water Mist SPF 18 2 g/100mL

Avobenzone, Homosalate, Octisalate, Octocrylene · SPRAY · Bentley Laboratories, LLC

No Recall History

Plain English

COOLA Refreshing Water Mist SPF 18 is a spray containing avobenzone, homosalate, octisalate, octocrylene at 2 g/100mL, taken topical. Manufactured by Bentley Laboratories, LLC.

Key Facts

Brand Name: COOLA Refreshing Water Mist SPF 18
Generic Name: Avobenzone, Homosalate, Octisalate, Octocrylene
NDC Code (Product): 54111-148
Manufacturer: Bentley Laboratories, LLC
Strength: 2 g/100mL
Dosage Form: SPRAY
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 07/30/2020

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 • shake well • apply liberally 15 minutes before sun exposure • reapply: •after swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this 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: 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

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 doctor if skin rash occurs

Frequently Asked Questions

What is COOLA Refreshing Water Mist SPF 18 used for?

COOLA Refreshing Water Mist SPF 18 contains Avobenzone, Homosalate, Octisalate, Octocrylene. It is a spray taken topical. Consult your doctor for specific uses.

Is COOLA Refreshing Water Mist SPF 18 a controlled substance?

COOLA Refreshing Water Mist SPF 18 is not classified as a controlled substance by the DEA.

What is the generic name for COOLA Refreshing Water Mist SPF 18?

The generic name for COOLA Refreshing Water Mist SPF 18 is Avobenzone, Homosalate, Octisalate, Octocrylene. There are 12 other brand versions of Avobenzone, Homosalate, Octisalate, Octocrylene.

What is the NDC code for COOLA Refreshing Water Mist SPF 18 2 g/100mL?

The NDC (National Drug Code) for COOLA Refreshing Water Mist SPF 18 2 g/100mL is 54111-148, listed by Bentley Laboratories, LLC.

Product NDC

54111-148

Package NDC

54111-148-50

Other Avobenzone, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)