HYDRA SPF 34

HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE TOPICAL HUMAN OTC DRUG

HYDRA SPF 34 is an FDA drug label for the active ingredient HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE manufactured by Drmtlgy, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260421.

Generic name
HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE
Manufacturer
Drmtlgy, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
83286-017
Application
M020
Label effective
20260421

About this product

HYDRA SPF 34 is an FDA-registered drug product whose active ingredient is HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE. It is labelled by Drmtlgy, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83286-017, application M020, label effective 20260421. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk skin, aging caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Homosalate 10.00% Octyl Salicylate 5.00% Avobenzone 3.00%

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 • Apply liberally 15 minutes before sun exposure • Reapply: • After 40 minutes of swimming sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months of age: Ask a doctor 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.

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 HYDRA SPF 34 used for?
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

Who makes HYDRA SPF 34?
Drmtlgy, LLC is the labeler of record for HYDRA SPF 34.

What form does HYDRA SPF 34 come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is HYDRA SPF 34 prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has HYDRA SPF 34 been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.