SKIN BALANCING ULTRA SHEER DAILY DEFENCE SPF 30 PAULAS CHOICE- avobenzone, homosalate, octocrylene, oxybenzone cream

Skin Balancing Ultra Sheer Daily Defence SPF 30 by

Drug Labeling and Warnings

Skin Balancing Ultra Sheer Daily Defence SPF 30 by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients             Purpose

Avobenzone 3.0% ........... Sunscreen
Homosalate 7.0% ............ Sunscreen

Octocrylene 2.0% ............ Sunscreen

Oxybenzone 4.0% ............ Sunscreen

PURPOSE

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 sun.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minutes before sun exposure
• Use a  water-resistant sunscreen if swimming or sweating:
•       Imeediately after towel drying
•       At least every two hours
• 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 of 15 or higher and other sun protection measures, including:

• Limit time in the sun, especially from 10AM - 2PM
• Wear long-sleeve shirts, pants, hats and sunglasses

INACTIVE INGREDIENT

Water (Aqua), Butylene Glycol, Silica, Aluminum Starch Octenylsuccinate, Cetyl Dimethicone, Camelia Sinensis (Green Tea) Leaf Extract, Aloe Barbadensis Leaf Juice Powder, Ascorbyl Palmitate, Phospholipids, Superoxide Dismutase, Adenosine, Tocopherol, Bisabolol, Boerhavia Diffusa Root Extract, Colloidal Oatmeal, Panthenol, Ginkgo Biloba Leaf Extract, Salix Alba (Willow) Bark Extract, Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Titanium Dioxide, Sodium Hydorxide, Steareth-21, Steareth-2, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sorbic Acid

PRINCIPAL DISPLAY PANEL

Paula's Choice

Skin Balancing Ultra-Sheer Daily Defense

Broad Spectrum SPF 30

60ml / 2 fl. oz.

INGREDIENTS AND APPEARANCE

SKIN BALANCING ULTRA SHEER DAILY DEFENCE SPF 30  PAULAS CHOICE
avobenzone, homosalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
ADENOSINE (UNII: K72T3FS567)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)
OATMEAL (UNII: 8PI54V663Y)
PANTHENOL (UNII: WV9CM0O67Z)
GINKGO (UNII: 19FUJ2C58T)
SALIX ALBA BARK (UNII: 205MXS71H7)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5001-1	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	08/12/2016
2	NDC: 56152-5001-2	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/12/2016

Labeler - Cosmetic Enterprises Ltd (017701475)

Registrant - Cosmetic Enterprises Ltd (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture(56152-5001)