Country: United States
Language: English
Source: NLM (National Library of Medicine)
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
NAKED SUNDAY PTY LTD
TOPICAL
OTC DRUG
SUNSCREEN - Helps prevents sunburn - If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun. If rash occurs
OTC monograph not final
GLOW GO LIP OIL SPF50- AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, (SUNSCREENS) OIL NAKED SUNDAY PTY LTD _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._ ---------- NAKED SUNDAYS SPF50+ GLOW + GO LIP OIL ACTIVE INGREDIENTS AVOBENZONE 3 % HOMOSALATE 10% OCTISALATE 5 % OCTOCRYLENE 10% PURPOSE SUNSCREEN USE - Helps prevents sunburn - If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun. WARNINGS FOR EXTERNAL USE ONLY - Do not use on damaged or broken skin. keep out of eyes, Rinse with water to remove STOP USE & ASK DOCTOR If rash occurs If product is swallowed , get medical help or contact a poison control center right away DIRECTIONS - Apply 20 minutes before sun exposure - Use a water resistant sunscreen if swimming or sweating - Re-apply frequently especially after swimming excercising or towel drying - Re-apply 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 inclusing: - limit time in the sun, especially from 10:00 AM- 02:00 PM - Wear long- Sleeved shirts , pants, Hats and sunglasses INGREDIENTS Candelilla wax, Ethylhexylglycerin, Flavour, Isopropyl myristate, MICA, Octyldodecanol, Phenoxyethanol, Polybutene, Raspberry oil, Tomato extract, Watermelon oil Protect the product in this container from excessive heat & direct sun LABEL Label GLOW GO LIP OIL SPF50 avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, (sunscreens) oil PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:81104-111 ROUTE OF ADMINISTRATION TOPICAL ACTIVE IN Read the complete document