TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN- octinoxate, octisalate and zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Allergan, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen Sunscreen Sunscreen - 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN- OCTINOXATE,
OCTISALATE
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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TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN
_DRUG FACTS_
ACTIVE INGREDIENTS
Octinoxate 7.5%
Octisalate 3.0%
Zinc Oxide 8.0%
PURPOS E
Sunscreen
Sunscreen
Sunscreen
US ES
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 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
reapply at least every 2 hours and after towel drying, swimming, or
sweating to avoid lowering
protection
SUN PROTECTION MEASURES UV exposure from 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, Caprylic/Capric Triglyceride, Silica, Squalane, Glycerin,
Niacinamide, Dimethicone, Glyceryl
Stearate, PEG-100 Stearate, Cetearyl Alcohol, Butyrospermum Parkii
(Shea) Butter, Polygonum
Aviculare Extract, Physalis Angulata Extract, Dunaliella Salina
Extract, Ubiquinone, Camellia Sinensis
Leaf Extract, Tremella Fuciformis Sporocarp Extract, Betaine, Melanin,
Tocopheryl Acetate,
Tocopherol, Hydroxyacetophenone, Batyl Alcohol, C12-15 Alkyl Benzoate,
Panthenol, Butylene
Glycol, Ceteareth-20,