PEARLIXIME ILLUMINATING PERFECTING SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octocrylene cream

Pearlixime ILLUMINATING PERFECTING Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Pearlixime ILLUMINATING PERFECTING Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by IXXI S.A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 10%

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 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:

INGREDIENTS AND APPEARANCE

PEARLIXIME ILLUMINATING PERFECTING SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70532-005
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 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70532-005-01	1 in 1 CARTON	04/03/2016
1		50 mL 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	04/01/2016

Labeler - IXXI S.A.S. (263290505)