COOLA Mineral Body SPF 30 Tropical Coconut 14.2 g/100mL

Zinc Oxide · LOTION · COOLA, LLC

No Recall History

Plain English

COOLA Mineral Body SPF 30 Tropical Coconut is a lotion containing zinc oxide at 14.2 g/100mL, taken topical. Manufactured by COOLA, LLC.

Key Facts

Brand Name: COOLA Mineral Body SPF 30 Tropical Coconut
Generic Name: Zinc Oxide
NDC Code (Product): 79753-053
Manufacturer: COOLA, LLC
Strength: 14.2 g/100mL
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 11/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective506 reports

macular degeneration453 reports

off label use313 reports

pyrexia303 reports

nausea284 reports

pain280 reports

malaise259 reports

weight decreased235 reports

therapeutic product effect incomplete213 reports

headache201 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 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours Sun Protection Measure : 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. to 2 p.m. • Wear long-sleeved shirts, pants, hats, and sun glasses.

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 skin rash occurs.

Frequently Asked Questions

What is COOLA Mineral Body SPF 30 Tropical Coconut used for?

COOLA Mineral Body SPF 30 Tropical Coconut contains Zinc Oxide. It is a lotion taken topical. Consult your doctor for specific uses.

Is COOLA Mineral Body SPF 30 Tropical Coconut a controlled substance?

COOLA Mineral Body SPF 30 Tropical Coconut is not classified as a controlled substance by the DEA.

What is the generic name for COOLA Mineral Body SPF 30 Tropical Coconut?

The generic name for COOLA Mineral Body SPF 30 Tropical Coconut is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for COOLA Mineral Body SPF 30 Tropical Coconut 14.2 g/100mL?

The NDC (National Drug Code) for COOLA Mineral Body SPF 30 Tropical Coconut 14.2 g/100mL is 79753-053, listed by COOLA, LLC.

Product NDC

79753-053

Package NDC

79753-053-01

Other Zinc 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)