Sisleya Global Anti-age Hand Care Cream
FDA Label NDC 66097-001

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 Sisleya Global Anti-age Hand Care (NDC 66097-001). 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 2%
Octinoxate 5%
Octisalate 3%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

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 our 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 from excessive heat or direct sun.

Inactive Ingredients

water, tribehenin peg-20 esters, sorbitol, isodecyl neopentanoate, butyrospermum parkii (shea butter), tropaeolum majus flower extract, helianthus annuus (sunflower) seed oil, glycyrrhiza glabra (licorice) root extract, harpagophytum procumbens root extract, cyclopentasiloxane, propylene glycol, phenoxyethanol, tocopheryl acetate, panthenol, pyrus malus (apple) seed extract, hexyldecanol, potassium cetyl phosphate, benzoic acid, sodium hydroxide, c12-13 pareth-23, methylparaben, aniba rosaeodora (rosewood) wood oil,edetate sodium, allantoin, c13-14 isoparaffin, retinyl palmitate, lavandula angustifolia (lavender) oil, pelargonium graveolens oil, caprylic/capric triglyceride, ethylparaben, citric acid, laureth-7, propylparaben, bht, ethylhexylglycerin, tocopherol, linalool, limonene, geraniol, citronellol, benzyl benzoate

Package Label.Principal Display Panel

SISLEYA  Global Anti-Age  Hand care   Sunscreen Cream Broad Spectrum SPF 15  NET WT. 0.14 OZ.  4 g  sisley PARIS   Sisley USA 7 Renaissance Square, 3rd Floor, White Plains, NY 10601   Distributed by:  C.F.E.B. sisley 16, avenue George V 75008 PARIS  www.sisley-usa.com  Made in France

Product Labels

Tube (Tube)

Tube (Tube)

Box (Box)

Box (Box)

* Please review the disclaimer below.