SHADE and ILLUMINATE SOFT RAD PRMR SPF

SHADE and ILLUMINATE SOFT RAD PRMR SPF is an FDA-registered drug product whose active ingredient is OCTINOXATE,OCTISALATE,ZINC OXIDE. It is labelled by TOM FORD BEAUTY DIST taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 76398-013, application M020, label effective 20231201. 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.

Across FDA labelling, products containing OCTINOXATE,OCTISALATE,ZINC OXIDE are most often described in connection with: helps prevent. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USE Helps prevent sunburn

Directions For sunscreen use: • apply liberally and evenly 15 minutes before sun exposure • reapply at least every two 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 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 product is swallowed, get medical help or contact a Poison Control Center right away.

What is SHADE and ILLUMINATE SOFT RAD PRMR SPF used for?
USE Helps prevent sunburn

Who makes SHADE and ILLUMINATE SOFT RAD PRMR SPF?
TOM FORD BEAUTY DIST is the labeler of record for SHADE and ILLUMINATE SOFT RAD PRMR SPF.

What form does SHADE and ILLUMINATE SOFT RAD PRMR SPF 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 SHADE and ILLUMINATE SOFT RAD PRMR SPF 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 SHADE and ILLUMINATE SOFT RAD PRMR SPF 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.