ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C

OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE TOPICAL HUMAN OTC DRUG

ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C is an FDA drug label for the active ingredient OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE manufactured by BEL STAR S.A. 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 20260724.

Generic name
OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer
BEL STAR S.A.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
14141-592
Application
M020
Label effective
20260724

About this product

ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C is an FDA-registered drug product whose active ingredient is OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE. It is labelled by BEL STAR S.A. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 14141-592, application M020, label effective 20260724. It is one of 5 FDA drug label records sharing the active ingredient OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE. 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 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE are most often described in connection with: uso ayuda, prevenir quemaduras. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Ingredientes activos OCTINOXATE 3% TITANIUM DIOXIDE 6.24% ZINC OXIDE 4.90%

Indications & Usage

Uso Ayuda a prevenir quemaduras solares

Dosage & Administration

Instrucciones Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol. Reaplicar por lo menos cada dos horas. Use un protector solar resistente al agua si usted nada o suda. Niños menores a 6 meses de edad: Consulte al médico

Warnings

Advertencias Alerta de Cáncer en la piel / envejecimiento de la piel : Pasar tiempo bajo el sol incrementa el riesgo de cáncer y envejecimiento prematuro de la piel. Este producto ha demostrado que unicamente ayuda a prevenir las quemaduras solares pero no previene el cáncer a la piel ni el envejecimiento prematuro de la misma. Sólo para uso externo. No usar en piel dañada o lastimada. Cuando use este producto mantener alejado de los ojos. Enjuagar con agua para eliminar. Detenga su uso y consulte al doctor si sucede enrojecimiento. Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente

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How products containing OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE compare

FDA lists 5 drug label records with OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE 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
— — LABORATOIRES M&L 2
— — BEL STAR S.A. 1
— — Boscia LLC 1
— — Parfums Christian Dior 1
— — — —

Frequently asked questions

What is ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C used for?
Uso Ayuda a prevenir quemaduras solares

Who makes ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C?
BEL STAR S.A. is the labeler of record for ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C. 5 FDA label records share the active ingredient OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, 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 ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C 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 ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C 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 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE?
Yes. 5 FDA drug label records list OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE 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 ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C 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.