Country: United States
Language: English
Source: NLM (National Library of Medicine)
Octinoxate 7.5%, Octisalate 3.0%, Zinc Oxide 8.0%
Allergan, Inc.
OTC DRUG
OTC monograph not final
ESSENTIAL DEFENSE VITAL HYDRATION BROAD SPECTRUM SPF 36 SUNSCREEN TINTED- OCTINOXATE, OCTISALATE, 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._ ---------- _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 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, Caprylic/Capric Triglyceride, Squalane, Niacinamide, Dimethicone, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Silica, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Hydroxyacetophenone, Batyl Alcohol, PEG-12 Dimethicone, Butylene Glycol, Ceteareth-20, Polyhydroxystearic Acid, Isostearic Acid, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Aminomethyl Propanol, Caprylyl Glycol, Sorbic Acid, Phenoxyethanol, Iron Oxides (77491,77492,77499) OTHER INFORMATION Protect t Read the complete document