ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion

Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen by

Drug Labeling and Warnings

Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Allergan, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%

Zinc Oxide 12.0%

Purpose

Sunscreen

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 skin rash occurs

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

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Sun Protection Measures Spending time in the sun increases the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a.m.-2 p.m., and wearing protective clothing
• Children under 6 months: Ask a doctor

Inactive ingredients

Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Camellia Sinensis Leaf Extract, Polygonum Aviculare Extract, Tocopheryl Acetate, Sodium Hyaluronate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Butylene Glycol, Disodium EDTA, Sodium Hydroxide, Citric Acid, Caprylyl Glycol, Sorbic Acid, Phenoxyethanol, Ethylhexylglycerin

Other information

• Protect this product from excessive heat and direct sun
• Store at room temperature 15° - 30°C (59° - 86°F)

Questions or comments?

www.skinmedica.com

Principal Display Panel - Carton Label

SkinMedica®

ESSENTIAL
DEFENSE

EVERYDAY CLEAR™

BROAD SPECTRUM

SPF 47

SUNSCREEN

OILY &
COMBINATION SKIN

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g

Principal Display Panel - Tube Label

SkinMedica®

ESSENTIAL
DEFENSE

EVERYDAY CLEAR™

BROAD SPECTRUM

SPF 47

SUNSCREEN

OILY &
COMBINATION SKIN

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g

INGREDIENTS AND APPEARANCE

ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN 
zinc oxide and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-5738
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	120 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Niacinamide (UNII: 25X51I8RD4)
Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
Glycerin (UNII: PDC6A3C0OX)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.S) (UNII: RLA2U05Z4Q)
Polyisobutylene (1300 Mw) (UNII: 241BN7J12Y)
Butylene Glycol (UNII: 3XUS85K0RA)
.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)
Ethylhexylglycerin (UNII: 147D247K3P)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Edetate Disodium (UNII: 7FLD91C86K)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Caprylyl Glycol (UNII: 00YIU5438U)
Polygonum Aviculare Top (UNII: ZCD6009IUF)
Sodium Hydroxide (UNII: 55X04QC32I)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sorbic Acid (UNII: X045WJ989B)
Hyaluronate Sodium (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-5738-18	1 in 1 CARTON	03/16/2016
1		52.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0023-5738-25	6 in 1 CARTON	03/16/2016
2		7.1 g 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	03/16/2016

Labeler - Allergan, Inc. (144796497)