Country: United States
Language: English
Source: NLM (National Library of Medicine)
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Hylands
TOPICAL
OTC DRUG
Purpose Avobenzone Sunscreen Octinoxate Sunscreen Octisalate Sunscreen Octocrylene Sunscreen Uses • Helps prevent sunburn
OTC monograph final
HYLANDS NATURALS VANILLA SUNSCREEN LIP BALM SPF 15- BROAD SPECTRUM SPF 15 VANILLA LIP BALM STICK HYLANDS ---------- HYLANDS NATURALS VANILLA SUNSCREEN LIP BALM SPF 15 _DRUG FACTS_ _ACTIVE INGREDIENTS_ Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5% _PURPOSE_ Avobenzone Sunscreen Octinoxate Sunscreen Octisalate Sunscreen Octocrylene Sunscreen _USES_ • Helps prevent sunburn _WARNINGS_ FOR EXTERNAL USE ONLY • DO NOT USE • on damaged or broken skin. • STOP USE AND ASK A DOCTOR • if rash occurs. • WHEN USING THIS PRODUCT • keep out of eyes. Rinse with water to remove. • KEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or contact 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 • Children under 6 months of age: ASK A DOCTOR SUN PROTECTION MEASURES Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. INACTIVE INGREDIENTS: Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Tocopherol,Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil, Sunflower Seed Oil Glycerides, Canola Oil. *Organic OTHER INFORMATION_:_ Protect this product from excessive heat and direct sun. PRINCIPAL DISPLAY PACKAGE HYLAND'S SPF 15 NATURALS™ VANILLA SUNSCREEN LIP BALM Manufactured for Hyland's Inc., P.O. Box 61067, Los ngeles, CA 90061 REV001 | L391726 SAFETY SEAL res HYLANDS NATURALS VANILLA SUNSCREEN LIP BALM SPF 15 broad spectrum spf 15 vanilla lip balm stick PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:54973-4123 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH AVOBENZONE (UNII: G63QQF2NOX Read the complete document