ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 32 TINTED SUNSCREEN- titanium dioxide and zinc oxide lotion

Essential Defense Mineral Shield Broad Spectrum SPF 32 TINTED Sunscreen by

Drug Labeling and Warnings

Essential Defense Mineral Shield Broad Spectrum SPF 32 TINTED 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

Titanium Dioxide 5.0%

Zinc Oxide 6.0%

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, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Dimethicone/PEG-10/15 Cross polymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Caffeine, Camellia Oleifera Leaf Extract, Tocopheryl Acetate, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxvsilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Stearic Acid, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)

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

MINERAL SHIELD™

BROAD SPECTRUM

SPF 32

SUNSCREEN

POST PROCEDURE &

SENSITIVE SKIN

TINTED

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g

Principal Display Panel - Tube Label

SkinMedica®

ESSENTIAL
DEFENSE

MINERAL SHIELD™

BROAD SPECTRUM

SPF 32

SUNSCREEN

POST-PROCEDURE &
SENSITIVE SKIN

TINTED

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g

INGREDIENTS AND APPEARANCE

ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 32 TINTED SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-5675
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 g
Zinc oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc oxide	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.S) (UNII: RLA2U05Z4Q)
Butylene Glycol (UNII: 3XUS85K0RA)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Sodium Chloride (UNII: 451W47IQ8X)
PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: TYP81E471F)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ferric Oxide Yellow (UNII: EX438O2MRT)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
Sodium Citrate (UNII: 1Q73Q2JULR)
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
Ferric Oxide Red (UNII: 1K09F3G675)
Ethylhexylglycerin (UNII: 147D247K3P)
Camellia Oleifera Leaf (UNII: 5077EL0C60)
Triethoxycaprylylsilane (UNII: LDC331P08E)
.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)
Ferrosoferric Oxide (UNII: XM0M87F357)
Stearic Acid (UNII: 4ELV7Z65AP)
Caffeine (UNII: 3G6A5W338E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-5675-08	1 in 1 CARTON	03/16/2016
1		227 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0023-5675-25	6 in 1 CARTON	03/16/2016
2		7.1 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0023-5675-13	12 in 1 CARTON	03/16/2016
3		3.68 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 0023-5675-17	1 in 1 CARTON	03/16/2016
4		52.5 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)