SISLEYA GLOBAL ANTI-AGE HAND CARE SPF 15- avobenzone, octinoxate, octisalate cream

SISLEYA Global Anti-Age Hand care by

Drug Labeling and Warnings

SISLEYA Global Anti-Age Hand 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 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

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

INGREDIENTS AND APPEARANCE

SISLEYA GLOBAL ANTI-AGE HAND CARE   SPF 15
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66097-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
SORBITOL (UNII: 506T60A25R)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
SHEANUT OIL (UNII: O88E196QRF)
TROPAEOLUM MAJUS FLOWER (UNII: 7FV667B00B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
APPLE SEED (UNII: 33C88SEV0Z)
HEXYLDECANOL (UNII: 151Z7P1317)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
C12-13 PARETH-23 (UNII: J1WW1510L4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ROSEWOOD OIL (UNII: F2522O5L7B)
EDETATE SODIUM (UNII: MP1J8420LU)
ALLANTOIN (UNII: 344S277G0Z)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLPARABEN (UNII: 14255EXE39)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURETH-7 (UNII: Z95S6G8201)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BENZYL BENZOATE (UNII: N863NB338G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66097-001-04	1 in 1 BOX	01/20/2013
1		4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 66097-001-76	1 in 1 BOX	01/20/2013
2		76 g in 1 TUBE; 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	01/20/2013

Labeler - C.F.E.B. Sisley (262279246)