PEARLIXIME ILLUMINATING PERFECTING SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octocrylene cream 
IXXI S.A.S.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pearlixime ILLUMINATING PERFECTING CREAM Sunscreen Broad Spectrum SPF 15

Drug Facts

Active ingredients

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 10%

Purpose

Sunscreen

Uses

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 ues 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

Sun Protection Measures. Speanding 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 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: Ask a doctor.

Other Information

• Protect the product inthis container from excessive heat and direct sun.

Inactive ingredients

water (aqua), glycerin, cetearyl alcohol, glyceryl stearate citrate, pentylene glycol, butylene glycol, rice (Oryza sative) powder, fragrance (parfum), sodium polyacrylate, sodium stearoyl glutamate, palmitoyl pine bark extract, kiwi (Actinidia chinensis) fruit water,  ethylhexylglycerin, sucrose laurate, hydrogenated starch hydrosylate, chlorphenesin, xanthan gum, alcohol, sucrose dilaurate, tocopherol, shrubby sophota (sophora flavescens) root extract, wild soybean (glycine soja) oil, sodium phytate, sucrose trilaurate, palmitic acid, hydrolyzed algae extract, bog bean (Menyanthes trifoliata) leaf extract, BHT, ascorbic acid, citric acid, sodium hydroxide.

Questions?

Call toll-free 1-800-322-3507

Package Labeling:

Label4

PEARLIXIME ILLUMINATING PERFECTING SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70532-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
RICE BRAN (UNII: R60QEP13IC)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
KIWI FRUIT OIL (UNII: 66086CWP3Q)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SUCROSE LAURATE (UNII: 05Q7CD0E49)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALCOHOL (UNII: 3K9958V90M)  
SUCROSE DILAURATE (UNII: 5926LC4S7M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
PALMITIC ACID (UNII: 2V16EO95H1)  
MENYANTHES TRIFOLIATA (UNII: 7H0QTZ446K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70532-005-011 in 1 CARTON04/03/2016
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2016
Labeler - IXXI S.A.S. (263290505)

Revised: 4/2016
Document Id: 2fadeab1-769b-62ee-e054-00144ff88e88
Set id: 17c5a026-dbd1-4095-926c-983356ecb180
Version: 2
Effective Time: 20160404
 
IXXI S.A.S.