SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS- avobenzone, homosalte, octisalate, octocrylene cream

SUNLEYA Age minimizing sun care by

Drug Labeling and Warnings

SUNLEYA Age minimizing sun care by is a Otc medication manufactured, distributed, or labeled by C.F.E.B. Sisley. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 

Product Labels

INGREDIENTS AND APPEARANCE

SUNLEYA AGE MINIMIZING SUN CARE   SPF 50 PLUS
avobenzone, homosalte, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66097-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SHEANUT OIL (UNII: O88E196QRF)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
PHYSALIS ALKEKENGI CALYX (UNII: AL7F9NO9HR)
CUCUMBER (UNII: YY7C30VXJT)
MANGANESE CARBONATE (UNII: 9ZV57512ZM)
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)
SAGE OIL (UNII: U27K0H1H2O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66097-003-51	1 in 1 BOX	01/21/2013
1		51.5 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/21/2013

Labeler - C.F.E.B. Sisley (262279246)