Drugplain

Coola Bare Republic Mineral Body Gel-Lotion SPF 30 18.2 g/100mL

ZINC OXIDE 18.2% · LOTION · COOLA LLC

No Recall History
Plain English

Coola Bare Republic Mineral Body Gel-Lotion SPF 30 is a lotion containing zinc oxide 18.2% at 18.2 g/100mL, taken topical. Manufactured by COOLA LLC.

Key Facts

Brand Name
Coola Bare Republic Mineral Body Gel-Lotion SPF 30
Generic Name
ZINC OXIDE 18.2%
NDC Code (Product)
79753-042
Manufacturer
COOLA LLC
Strength
18.2 g/100mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
03/02/2020

Recall History

No Recall History

Side Effects Reported to FDA

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

sepsis2 reports
abdominal abscess1 reports
abscess1 reports
blood magnesium decreased1 reports
bradycardia1 reports
candida infection1 reports
candida test positive1 reports
diarrhoea1 reports
encephalopathy1 reports
enterococcus test positive1 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 40 minutes of 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 skin 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-sleeve 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 Bare Republic Mineral Body Gel-Lotion SPF 30 used for?

Coola Bare Republic Mineral Body Gel-Lotion SPF 30 contains ZINC OXIDE 18.2%. It is a lotion taken topical. Consult your doctor for specific uses.

Is Coola Bare Republic Mineral Body Gel-Lotion SPF 30 a controlled substance?

Coola Bare Republic Mineral Body Gel-Lotion SPF 30 is not classified as a controlled substance by the DEA.

What is the generic name for Coola Bare Republic Mineral Body Gel-Lotion SPF 30?

The generic name for Coola Bare Republic Mineral Body Gel-Lotion SPF 30 is ZINC OXIDE 18.2%. There are 1 other brand versions of ZINC OXIDE 18.2%.

What is the NDC code for Coola Bare Republic Mineral Body Gel-Lotion SPF 30 18.2 g/100mL?

The NDC (National Drug Code) for Coola Bare Republic Mineral Body Gel-Lotion SPF 30 18.2 g/100mL is 79753-042, listed by COOLA LLC.

Product NDC

79753-042

Package NDC

79753-042-01

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

Data from openFDA · Public domain (CC0 1.0)