Drugplain

Dermatone SPF 30 1.8 g/100mL

Avobenzone, Homosalate, Octisalate, Octocrylene · LOTION · Dermatone Labs LLC

No Recall History
Plain English

Dermatone SPF 30 is a lotion containing avobenzone, homosalate, octisalate, octocrylene at 1.8 g/100mL, taken topical. Manufactured by Dermatone Labs LLC.

Key Facts

Brand Name
Dermatone SPF 30
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
NDC Code (Product)
54414-048
Manufacturer
Dermatone Labs LLC
Strength
1.8 g/100mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
06/26/2022

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

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 ٠Hold container 4 to 6 inches from the skin to apply. ٠Do not spray directly into face. Spray on hands then apply to face. ٠Do not apply in windy conditions. ٠Use in a well-ventilated area. ٠For sunscreen use ٠apply to all areas of the skin exposed to the sun. ٠Reapply as needed or after towel drying, swimming, or sweating.

Warnings

WARNINGS For external use only. Highly Flammable: Do not apply or use product near heat, flame, or while smoking. When using this product: • keep out of eyes. Rinse with water to remove. • Keep away from face to avoid breathing it. • Do not puncture or incinerate, Contents under pressure • Do not store at temperature above 120⁰F 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 Dermatone SPF 30 used for?

Dermatone SPF 30 contains Avobenzone, Homosalate, Octisalate, Octocrylene. It is a lotion taken topical. Consult your doctor for specific uses.

Is Dermatone SPF 30 a controlled substance?

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

What is the generic name for Dermatone SPF 30?

The generic name for Dermatone SPF 30 is Avobenzone, Homosalate, Octisalate, Octocrylene. There are 12 other brand versions of Avobenzone, Homosalate, Octisalate, Octocrylene.

What is the NDC code for Dermatone SPF 30 1.8 g/100mL?

The NDC (National Drug Code) for Dermatone SPF 30 1.8 g/100mL is 54414-048, listed by Dermatone Labs LLC.