Cetaphil Tinted Daily Facial Moisturizer SPF 50

Cetaphil Tinted Daily Facial Moisturizer SPF 50 is an FDA-registered drug product whose active ingredient is HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE. It is labelled by Galderma Laboratories, L.P. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0299-4147, application M020, label effective 20260716. It is one of 12 FDA drug label records sharing the active ingredient HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE. 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 HOMOSALATE, OCTOCRYLENE, OCTISALATE, 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.

Use(s) 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

Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of 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 10am-2pm wear long-sleeved shirts, pants, hats and sunglasses

Warnings For external use only.

FDA lists 12 drug label records with HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Cetaphil Tinted Daily Facial Moisturizer SPF 50 used for?
Use(s) 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 Cetaphil Tinted Daily Facial Moisturizer SPF 50?
Galderma Laboratories, L.P. is the labeler of record for Cetaphil Tinted Daily Facial Moisturizer SPF 50. 12 FDA label records share the active ingredient HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Cetaphil Tinted Daily Facial Moisturizer SPF 50 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 Cetaphil Tinted Daily Facial Moisturizer SPF 50 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.

Are there other products containing HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE?
Yes. 12 FDA drug label records list HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Cetaphil Tinted Daily Facial Moisturizer SPF 50 been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.