Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25
FDA Label NDC 13537-921

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ventura Corporation Ltd for the product Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25 (NDC 13537-921). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 4 G Tube Box - (marron Glamour) - Brown

→ Principal Display Panel - 4 G Tube Box - (rojo Deseo) - Red

→ Principal Display Panel - 4 G Tube Box - (rojo Intrigante) - Red

→ Principal Display Panel - 4 G Tube Box - (rojo Lujuria) - Red

→ Principal Display Panel - 4 G Tube Box - (coral Chic) - Pink

→ Principal Display Panel - 4 G Tube Box - (rosa Encanto) - Pink

→ Principal Display Panel - 4 G Tube Box - (borgona Sexy) - Purple

→ Principal Display Panel - 4 G Tube Box - (fucsia Cautivante) - Pink

→ Principal Display Panel - 4 G Tube Box - (granate Seductor) - Purple

→ Principal Display Panel - 4 G Tube Box - (rosa Romantica) - Pink

→ Principal Display Panel - 4 G Tube Box - (naranja Primavera) - Orange

→ Principal Display Panel - 4 G Tube Box - (frambuesa Mania) - Red

→ Principal Display Panel - 4 G Tube Box - (rosa Dulzura) - Pink

→ Principal Display Panel - 4 G Tube Box - (pimienta Caliente) - Brown

→ Principal Display Panel - 4 G Tube Box - (canela Nude) - Orange

→ Principal Display Panel - 4 G Tube Box - (mora Glam) - Brown

→ Principal Display Panel - 4 G Tube Box - (coral Intense) - Red

→ Principal Display Panel - 4 G Tube Box - (fresa Coqueta) - Red

→ Principal Display Panel - 4 G Tube Box - (pimienta Caliente Femme) - Red

→ Principal Display Panel - 4 G Tube Box - (granate Seductor Femme) - Purple

→ Principal Display Panel - 4 G Tube Box - (fucsia Cautivante Femme) - Pink

→ Principal Display Panel - 4 G Tube Box - (rosa Romantica Femme) - Pink

→ Principal Display Panel - 4 G Tube Box - (rojo Intrigante Femme) - Red

→ Principal Display Panel - 4 G Tube Box - (rosa Encanto Femme) - Pink

Other

Drug Facts

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.
For external use only.

P.R.: Dist. by Ventura Corp, Ltd., San
Juan, Puerto Rico 00926.

Otc - Purpose

Active Ingredients	Purpose
OCTINOXATE: 6.6%	Sunscreen
OXYBENZONE: 1.5%	Sunscreen

Uses

Helps prevent sunburn.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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

Directions

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

Protect this product in this container form excesive heat and direct sun. Keep away from heat sources and direct sunlight. Store well and under 50°C (112°F).

Inactive Ingredients

DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, ETHYLHEXYL PALMITATE, OZOKERITE, WATER, POLYETHYLENE, TRIDECYL STEARATE, POLYGLYCERYL-3 DIISOSTEARATE, POLYMETHYL METHACRYLATE, COPERNICIA CERIFERA (CARNAUBA) WAX, GLYCERIN, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, FRAGRANCE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM STARCH OCTENYLSUCCINATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN, PROPYLENE GLYCOL, LIMONIUM GERBERI EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCINE SOJA OIL (GLYCINE SOJA (SOYBEAN) OIL), TOCOPHEROL, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SILICA, SODIUM CHLORIDE,VITIS VINIFERA (GRAPE) FRUIT EXTRACT

May contain:
MICA,IRON OXIDES, TITANIUM DIOXIDE, YELLOW 5 LAKE, RED 21 LAKE, RED 7 LAKE, RED 27 LAKE, TALC, RED 30 LAKE, PEG-8 METHYL ETHER TRIETHOXYSILANE, CARMINE.