ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM

AVOBENZONE, HOMOSALATE, OCTISALATE TOPICAL HUMAN OTC DRUG

ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM is an FDA drug label for the active ingredient AVOBENZONE, HOMOSALATE, OCTISALATE manufactured by SEORIN COMPANY Co., Ltd. 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 20260420.

Generic name
AVOBENZONE, HOMOSALATE, OCTISALATE
Manufacturer
SEORIN COMPANY Co., Ltd.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
84616-007
Application
M020
Label effective
20260420

About this product

ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM is an FDA-registered drug product whose active ingredient is AVOBENZONE, HOMOSALATE, OCTISALATE. It is labelled by SEORIN COMPANY Co., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84616-007, application M020, label effective 20260420. It is one of 24 FDA drug label records sharing the active ingredient AVOBENZONE, HOMOSALATE, OCTISALATE. 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 AVOBENZONE, HOMOSALATE, OCTISALATE 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

Actives Ingredients Avobenzone 2.7% Homosalate 13.5% Octisalate 4.5%

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 and evenly 15 minutes before sun exposure. Sun protection measures. ​Spending time in the sun increases your 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 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor reapply at least every 2 hours. use a water-resistant sunscreen if swimming or sweating

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.

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How products containing AVOBENZONE, HOMOSALATE, OCTISALATE compare

FDA lists 24 drug label records with AVOBENZONE, HOMOSALATE, OCTISALATE 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.

Dosage formProductsManufacturerProducts
— — Koco Life LLC 5
— — SEORIN COMPANY Co., Ltd. 4
— — The Kroger Co. 3
— — Topco Associates LLC 3
— — COSMAX USA., CORP 2

Frequently asked questions

What is ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 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 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM?
SEORIN COMPANY Co., Ltd. is the labeler of record for ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM. 24 FDA label records share the active ingredient AVOBENZONE, HOMOSALATE, OCTISALATE, 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 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 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 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 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 AVOBENZONE, HOMOSALATE, OCTISALATE?
Yes. 24 FDA drug label records list AVOBENZONE, HOMOSALATE, OCTISALATE 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 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 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.