RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20

RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 TOPICAL HUMAN OTC DRUG

RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 is an FDA drug label for the active ingredient RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 manufactured by PML NYC, 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 20260417.

Generic name
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20
Manufacturer
PML NYC, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
59735-800
Application
M020
Label effective
20260417

About this product

RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 is an FDA-registered drug product whose active ingredient is RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20. It is labelled by PML NYC, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 59735-800, application M020, label effective 20260417. 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 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 are most often described in connection with: ask doctor, rash occurs. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

ACTIVE INGREDIENTS Avobenzone 2% Octinoxate 7.5% Octisalate 5%

Indications & Usage

Stop use and ask a doctor if rash occurs.

Dosage & Administration

DIRECTIONS 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 risk of skin cancer and early 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 10:00 a.m. - 2:00 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. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.

Frequently asked questions

What is RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 used for?
Stop use and ask a doctor if rash occurs.

Who makes RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20?
PML NYC, LLC is the labeler of record for RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20.

What form does RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 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 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 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 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 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.