Drugplain

Broad Spectrum SPF 30 Sunscreen 8.25 g/44mL

Broad Spectrum SPF 30 Sunscreen · LOTION · Raining Rose

1 Recall on Record
Plain English

Broad Spectrum SPF 30 Sunscreen is a lotion containing broad spectrum spf 30 sunscreen at 8.25 g/44mL, taken topical. Manufactured by Raining Rose.

Key Facts

Brand Name
Broad Spectrum SPF 30 Sunscreen
Generic Name
Broad Spectrum SPF 30 Sunscreen
NDC Code (Product)
65692-0566
Manufacturer
Raining Rose
Strength
8.25 g/44mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
05/13/2021

Recall History

1 Recall on Record
Class II05/17/2022

Family Dollar Stores, Llc.

cGMP deviations: product stored outside of labeled temperature requirements.

OngoingVoluntary: 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 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 For sunscreen use: ● apply liberally 15 minutes before sun exposure ● reapply at least every 2 hours ● use a 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-sleeved shirts, pants, hats, and sunglasses ● children under 6 months of age: Ask a doctor

Warnings

Warnings For external use only

Frequently Asked Questions

What is Broad Spectrum SPF 30 Sunscreen used for?

Broad Spectrum SPF 30 Sunscreen contains Broad Spectrum SPF 30 Sunscreen. It is a lotion taken topical. Consult your doctor for specific uses.

Is Broad Spectrum SPF 30 Sunscreen a controlled substance?

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

What is the generic name for Broad Spectrum SPF 30 Sunscreen?

The generic name for Broad Spectrum SPF 30 Sunscreen is Broad Spectrum SPF 30 Sunscreen. There are no other listed brand versions of Broad Spectrum SPF 30 Sunscreen.

What is the NDC code for Broad Spectrum SPF 30 Sunscreen 8.25 g/44mL?

The NDC (National Drug Code) for Broad Spectrum SPF 30 Sunscreen 8.25 g/44mL is 65692-0566, listed by Raining Rose.

Product NDC

65692-0566

Package NDC

65692-0566-1

Other Broad Spectrum SPF 30 Sunscreen Dosages

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

Data from openFDA · Public domain (CC0 1.0)