COOLA CLASSIC SUNSCREEN FRAGRANCE FREE 30 mg/mL

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

No Recall History

Plain English

COOLA CLASSIC SUNSCREEN FRAGRANCE FREE is a lotion containing avobenzone, homosalate, octisalate, octocrylene at 30 mg/mL, taken topical. Manufactured by COOLA, LLC.

Key Facts

Brand Name: COOLA CLASSIC SUNSCREEN FRAGRANCE FREE
Generic Name: Avobenzone, Homosalate, Octisalate, Octocrylene
NDC Code (Product): 79753-045
Manufacturer: COOLA, LLC
Strength: 30 mg/mL
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 01/01/2018

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 CLASSIC SUNSCREEN FRAGRANCE FREE used for?

COOLA CLASSIC SUNSCREEN FRAGRANCE FREE contains Avobenzone, Homosalate, Octisalate, Octocrylene. It is a lotion taken topical. Consult your doctor for specific uses.

Is COOLA CLASSIC SUNSCREEN FRAGRANCE FREE a controlled substance?

COOLA CLASSIC SUNSCREEN FRAGRANCE FREE is not classified as a controlled substance by the DEA.

What is the generic name for COOLA CLASSIC SUNSCREEN FRAGRANCE FREE?

The generic name for COOLA CLASSIC SUNSCREEN FRAGRANCE FREE is Avobenzone, Homosalate, Octisalate, Octocrylene. There are 11 other brand versions of Avobenzone, Homosalate, Octisalate, Octocrylene.

What is the NDC code for COOLA CLASSIC SUNSCREEN FRAGRANCE FREE 30 mg/mL?

The NDC (National Drug Code) for COOLA CLASSIC SUNSCREEN FRAGRANCE FREE 30 mg/mL is 79753-045, listed by COOLA, LLC.

Product NDC

79753-045

Package NDC

79753-045-72

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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)