ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN- titanium dioxide and zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP), Zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z)

Available from:

Allergan, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen Sunscreen - 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35 SUNSCREEN-
TITANIUM DIOXIDE AND ZINC OXIDE LOTION
ALLERGAN, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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ESSENTIAL DEFENSE MINERAL SHIELD BROAD SPECTRUM SPF 35
_DRUG FACTS_
ACTIVE INGREDIENTS
Titanium Dioxide 5.0%
Zinc Oxide 6.0%
PURPOS E
Sunscreen
Sunscreen
US ES
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
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
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 temperat