Drugplain

SPF 30 Sunscreen 4.51 g/100mL

Zinc Oxide, Titanium Dioxide · LOTION · CLEURE

3 Recalls on Record
Plain English

This sunscreen lotion contains zinc oxide and titanium dioxide as active ingredients to protect your skin from harmful ultraviolet (UV) rays. It is applied directly to the skin and provides SPF 30 protection against sun damage.

Key Facts

Brand Name
SPF 30 Sunscreen
Generic Name
Zinc Oxide, Titanium Dioxide
NDC Code (Product)
83294-101
Manufacturer
CLEURE
Strength
4.51 g/100mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
08/22/2022

Recall History

3 Recalls on Record
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class II05/17/2022

Family Dollar Stores, Llc.

cGMP deviations: product stored outside of labeled temperature requirements.

OngoingVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective507 reports
macular degeneration453 reports
off label use316 reports
pyrexia304 reports
nausea290 reports
pain283 reports
malaise261 reports
weight decreased236 reports
therapeutic product effect incomplete214 reports
headache204 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps to 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 at least every 2 hours use water resistant sunscreen if swimming or sweating 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 sleeve 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 a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is SPF 30 Sunscreen used for?

This sunscreen lotion contains zinc oxide and titanium dioxide as active ingredients to protect your skin from harmful ultraviolet (UV) rays. It is applied directly to the skin and provides SPF 30 protection against sun damage.

Is SPF 30 Sunscreen a controlled substance?

SPF 30 Sunscreen is not classified as a controlled substance by the DEA.

What is the generic name for SPF 30 Sunscreen?

The generic name for SPF 30 Sunscreen is Zinc Oxide, Titanium Dioxide. There are 12 other brand versions of Zinc Oxide, Titanium Dioxide.

What is the NDC code for SPF 30 Sunscreen 4.51 g/100mL?

The NDC (National Drug Code) for SPF 30 Sunscreen 4.51 g/100mL is 83294-101, listed by CLEURE.