Essential Defense Mineral Shield Broad Spectrum Spf 35 Sunscreen Lotion
FDA Label NDC 0023-5703

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allergan, Inc. for the product Essential Defense Mineral Shield Broad Spectrum Spf 35 Sunscreen (NDC 0023-5703). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel - Carton Label

→ Principal Display Panel - Tube Label

Other

Drug Facts

Active Ingredients

Titanium Dioxide 5.0%

Zinc Oxide 6.0%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if skin rash occurs

Otc - Keep Out Of Reach Of Children

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 Crosspolymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Caffeine, Camellia Oleifera Leaf Extract, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Stearic Acid, Ethylhexylglycerin, Phenoxyethanol

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 35

SUNSCREEN

POST-PROCEDURE &
SENSITIVE SKIN

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g

Principal Display Panel - Tube Label