Esika Hydracolor 2 In 1 Spf 25
FDA Label NDC 13537-596

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 Spf 25 (NDC 13537-596). 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

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.

      • Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

Otc - Purpose

Active IngredientsPurpose
Octinoxate 6.64 %Sunscreen
Oxybenzone 1.51 %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.

    • Contains Oxybenzone

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

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 (SOYBEAN) OIL, TOCOPHEROL, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SILICA, SODIUM CHLORIDE, VITIS VINIFERA (GRAPE) FRUIT EXTRACT. MAY CONTAIN : MICA, TITANIUM DIOXIDE, RED 30 LAKE, IRON OXIDES, YELLOW 5 LAKE, RED 21 LAKE, RED 27 LAKE, RED 7 LAKE, TALC, BLUE 1 LAKE, PEG-8 METHYL ETHER TRIETHOXYSILANE, CARMINE.

Principal Display Panel - 4 G Tube Box – All Shades

HYDRACOLOR 2 IN 1
Highly Moisturizing and Coloring
Lipstick SPF 25

Net Weight 0.14 oz. e (4 g)

ésika

Principal Display Panel (4 g Tube Box – All Shades)

Principal Display Panel (4 g Tube Box – All Shades)

Principal Display Panel - Kit Carton

HYDRACOLOR 2 IN 1
Highly Moisturizing and Coloring
Lipstick SPF 25

ésika

Net Wt. 0.28 oz. e (8 g)

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

* Please review the disclaimer below.