Esika Pro HIDRACOLOR 3 in 1 Moisturizing, Color and Perfecting Effect SPF 25

Manufacturer
Ventura International LTD | Bel Star S.A. (Colombia)
Effective date
2017-04-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:43

Label at a glance#

ProductEsika Pro HIDRACOLOR 3 in 1 Moisturizing, Color and Perfecting Effect SPF 25
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
OCTINOXATE 7.5%Sunscreen
ZINC OXIDE 3.92%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

  • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

SPL UNCLASSIFIED SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, isononyl isononanoate, ozokerite, water, polyglyceryl-3 diisostearate, tridecyl stearate, polyethylene, copernicia cerifera (carnauba) wax, glycerin, neopentyl glycol dicaprylate/dicaprate, butyrospermum parkii (shea) butter, ptfe, sodium starch octenylsuccinate, tocopheryl acetate, caprylic/capric triglyceride, phenoxyethanol, cocos nucifera (coconut) oil, aloe barbadensis leaf extract, fragrance, ceramide 3, caprylyl glycol, chlorphenesin, dimethicone, triethoxycaprylylsilane, glycine soja (soybean) oil, limonium gerberi extract, trimethylsiloxysilicate, tocopherol, magnesium chloride, potassium chloride, silica, sodium chloride, crambe maritima extract, alpha-isomethyl ionone, d-limonene, linalool, amyl cinnamal, citronellol.

May Contain: red 30 lake, titanium dioxide, iron oxides, mica, red 27 lake, yellow 5 lake, red 7 lake, red 21 lake, talc, blue 1 lake, carmine.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int.
Ltd. DBA Belcorp USA, Miami, FL 33126.

PRINCIPAL DISPLAY PANEL - 4 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ésika
PRO

HIDRACOLOR
3 IN 1

Moisturizing Lipstick,
Color and Perfecting
Effect SPF 25

Net Weight
0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box
PRINCIPAL DISPLAY PANEL - 4 g Tube Box

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14783-11214783-112-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
34f77812-7c92-fa1c-e063-6294a90a35bfbb6183ef-7714-4767-84a9-5b48902f48872025-05-12WarningsExact identifier
spl set id: bb6183ef-7714-4767-84a9-5b48902f4887

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.