Country: United States
Language: English
Source: NLM (National Library of Medicine)
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)
Accra-Pac, Inc.
HOMOSALATE
HOMOSALATE 0.06 mL in 1 mL
TOPICAL
OTC DRUG
OTC monograph final
BANANA BOAT PROTECTIVE DRY SPF 10- HOMOSALATE AND OCTISALATE AND OCTOCRYLENE AND AVOBENZONE OIL ACCRA-PAC, 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._ ---------- BANANA BOAT PROTECTIVE DRY OIL SPF 10 ACTIVE INGREDIENTS: Homosalate 0.06mL / 1mL Octisalate 0.06mL / 1mL Octocrylene 0.025mL / 1mL Avobenzone 0.015mL / 1mL DIRECTIONS: Apply generously and evenly to all areas 20 minutes before sun exposure. No need to rub in. Reapply frequently to maintain protection and also after swimming and towel drying. Do not spray directly on face. Spray on hands to apply to face. Use in a well-ventilated area. For external use only. Avoid contact with eyes and clothes. USAGE ADVICE: Do not stay too long in the sun even while using a sun protection product. Keep babies and young children out of direct sunlight. Use clothing and sun protection products with a very high SPF (higher than 25) for babies and young children. Over exposure to the sun is a serious health threat. Reducing applied quantity will significantly lower the level of protection. WARNING: FLAMMABLE. Pressurized container. Protect from sunlight and do not expose to temperatures exceeding 50ºC. Do not pierce or burn, even after use. Do not spray on a naked flame, onto or near fire, or any incandescent material. Keep away from sources of ignition – no smoking. Use only as directed. Keep out of reach of children. INGREDIENTS: Alcohol Denat., Homosalate, Ethylhexyl Salicylate, Paraffinum liquidum, Diethylhexyl 2, 6- Naphthalate, Octocrylene, Butyl Methoxydibenzoylmethane,Vitis vinifera, Cocos nucifera, Caprylyl Glycol, Acrylates/ Octylacrylamide Copolymer, Aloe barbadensis, Retinyl Palmitate, Tocopherol, Dimethyl Capramide, Parfum. FLAMMABLE MADE IN U.S.A DISTRIBUTED BY: ENERGIZER GROUP LTD SWORD HOUSE, HP13 6DG HIGH WYCOMBE, UK www.bananaboat.co.uk PRINCIPAL DISPLAY PANEL CLEAR ULTRAMIS T BANANA BOA Read the complete document