RESIST WRINKLE DEFENSE SPF 30 PAULAS CHOICE- zinc oxide cream

Resist Wrinkle Defense SPF 30 by

Drug Labeling and Warnings

Resist Wrinkle Defense 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

Zinc Oxide 13.0% .................  Sunscreen

PURPOSE

Uses

• Helps prevent sunburn
• If used as directed with otehr sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the 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 AND PRECAUTIONS

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 seating:
•        Immediately after towel dyring
•        At least every two hours
• Children under 6 months of age: Ask a doctor

Sun ProtectionMeasures. 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 tim in the sun, especially from 10a.m.-2p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses 

INACTIVE INGREDIENT

Water (Aqua), Cyclopentasiloxane, PEG-12 Dimethicone, PEG/PPG-18/18 Dimethicone, Lauroyl Lysine, Sodium Chloride, Trihydroxystearin, Dimethicone Crosspolymer, Resveratrol, Quercetin, Epigalloactechin Gallate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Adenosine, Bisabolol, Salix Alba (Willow) Bark Extract, Punica Granatum (Pomegranate) Extract, Haematococus Pluvialis Extract, Hydrolyzed Corn Starch, Polysorbate 80, Hydrated Silica, Triethoxycaprylylsilane, C12-15 Alkyl Benzoate, Isopropyl Titanium Triisostearate, Hexylene Glycol, Ethylhexylglycerin, Iron Oxide (CI 77491, CI 77492, CI 77499), Caprylyl Glycol, Phenoxyethanol

PRINCIPAL DISPLAY PANEL

PAULA'S CHOICE

RESIST

Super-Light Daily

Wrinkle Defense

Broad Spectrum SPF 30

60 ml / 2 fl. oz.

INGREDIENTS AND APPEARANCE

RESIST WRINKLE DEFENSE SPF 30  PAULAS CHOICE
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
LAUROYL LYSINE (UNII: 113171Q70B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
RESVERATROL (UNII: Q369O8926L)
QUERCETIN (UNII: 9IKM0I5T1E)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ADENOSINE (UNII: K72T3FS567)
LEVOMENOL (UNII: 24WE03BX2T)
SALIX ALBA BARK (UNII: 205MXS71H7)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5003-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/10/2016
2	NDC: 56152-5003-2	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	08/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/10/2016

Labeler - Cosmetic Enterprises Ltd (017701475)

Registrant - Cosmetic Enterprises Ltd (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture(56152-5003)