Sunleya Age Minimizing Sun Care Cream
FDA Label NDC 66097-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by C.f.e.b. Sisley for the product Sunleya Age Minimizing Sun Care (NDC 66097-003). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts


Active Ingredients

Avobenzone 3 %
Octinoxate 5 %
Octisalate 5 %
Oxybenzone 4 %


Purpose

Sunscreen

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.

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.

Directions

  • Apply liberally 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.
  • Sun Protection Measures:  Spending time in the sun increases your risk of skin cancer and early skin 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 am to 2 pm.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

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

Inactive Ingredients

water, glycerin, butyrospermum parkii (shea butter), glyceryl stearate, peg-100 stearate, butylene glycol, potassium cetyl phosphate, silica, stearyl alcohol, tocopherol acetate, allantoin, physalis alkekengi calyx extract, cucumis sativus (cucumber) fruit extract, rhodochrosite extract, sodium acryloyldimethyltaurate/vp crosspolymer, xanthan gum, pentylene glycol, disodium edta, sodium hydroxide, citric acid, thymus mastichina flower oil, salvia officinalis (sage) oil, phenoxyethanol, phenoxyethanol, sorbic acid, potassium sorbate, linalool, limonene

Package Label.Principal Display Panel

SUNLEYA  Age minimizing sun care Sunscreen Cream Broad Spectrum SPF 50+ sisley PARIS  NET WT. 1.8 OZ.  51,5 g  CREATIONS HUBERT ISABELLE D'ORNANO   Sisley USA  7 Renaissance Square, 3rd Floor, White Plains, NY 10601 

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