PATRICIA WEXLER INTENSIVE 3-IN-1 DAY CREAM WITH SUNSCREEN BROAD SPECTRUM SPF 28- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Patricia Wexler Intensive 3-in-1 Day Cream with Sunscreen Broad Spectrum SPF 28 by

Drug Labeling and Warnings

Patricia Wexler Intensive 3-in-1 Day Cream with Sunscreen Broad Spectrum SPF 28 by is a Otc medication manufactured, distributed, or labeled by Bath & Body Works, Inc., Thibiant International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 2.7%, Oxybenzone 4.0%

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 immediately.

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. 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 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 in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

Water (Aqua, Eau), Butylene Glycol, Neopentyl Glycol Diheptanoate, Polyester-8, Cetyl Alcohol, Glycerin, Myristyl Nicotinate, Behenyl Alcohol, Polyethylene, Potato Starch Modified, Polysilicone-11, Di-C12-15 Alkyl Fumarate, Polymethyl Methacrylate, Glyceryl Stearate, PEG-100 Stearate, Pyrus Malus (Apple) Fruit Extract, Cinnamomum Cassia Bark Extract, Glycine Soja (Soybean) Seed Extract, Rheum Palmatum Root/Stalk Extract, Yeast Extract (Faex), Bacopa Monniera Extract, Olea Europaea (Olive) Fruit Extract, Cupressus Sempervirens (Cypress) Oil, Caffeine, Fermented Sweet Black Tea, Palmitoyl Tetrapeptide-7, Pearl Powder, Soy Amino Acids, Hydrolyzed Soy Protein, Hydrolyzed Silk, Palmitoyl Oligopeptide, Phospholipids, Dimethicone, Tetrahexyldecyl Ascorbate, Humic Acids, Carbomer, Hydrogenated Lecithin, Ethylhexylglycerin, Caprylyl Glycol, Laureth-12, Hexylene Glycol, Teprenone, Dipropylene Glycol, Polysorbate 20, Isobutyl Methyl Tetrahydropyranol, Pentadecalactone, Methyl Salicylate, Silica, Disodium EDTA, Isopropyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Mica, Titanium Dioxide (CI 77891), Yellow 5 (CI 19140), Red 40 (CI 16035).

COMPANY INFORMATION

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

PRODUCT PACKAGING

INGREDIENTS AND APPEARANCE

PATRICIA WEXLER INTENSIVE 3-IN-1 DAY CREAM WITH SUNSCREEN BROAD SPECTRUM SPF 28 
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-8047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62670-8047-6	48 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/30/2013

Labeler - Bath & Body Works, Inc. (878952845)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International Inc.		083913913	manufacture(62670-8047)