NDC | 63354-724-34 |
Set ID | 4daeaf6b-c58d-0a9b-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Edgewell Personal Care Brands LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
-
Flammable
Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
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Directions
■ hold container 4 to 6 inches from the skin to apply
■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ do not spray directly into face. Spray on hands then apply to face
■ do not apply in windy conditions
■ use in well-ventilated area
■ reapply: • after 80 minutes of swimming or sweating • immediately after
towel drying • at least every 2 hours
■ 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-sleeve shirts, pants, hats, and sunglasses
■ children under 6 months: Ask a doctor
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Inactive Ingredients
Alcohol Denat., Isobutane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Fragrance, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Ascorbyl Palmitate, Hydrogenated Methyl Abietate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract.
- Other Information
- Questions or Comments?
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PRINCIPAL DISPLAY PANEL
BANANA
BOAT (R)
Ultra
Defense (R)
CLEAR SUNSCREEN SPRAY
UVA/UVB BROAD SPECTRUM SPF 100
100
PROTECTS
AGAINST 99%
OF BURNING RAYS
LIGHTWEIGHT
High Endurance vs. Water
Water Resistant
(80 Minutes)
NET WT 6 OZ. (170 g)
CLEAR
UltraMist
BANANA
BOAT
Ultra
Defense
MAX Skin Protect
UVA/UVB PROTECTION
CONTINUOUS SPRAY SUNSCREEN
100
BROAD SPECTRUM
SPF 100
WATER RESISTANT
(80 MINUTES)
LIGHTWEIGHT & HYDRATING
VITAMIN E
PROTECTS AGAINST 99% OF BURNING RAYS
SWIM SPLASH SPORT
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-724 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O) DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18) ASCORBYL PALMITATE (UNII: QN83US2B0N) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MINERAL OIL (UNII: T5L8T28FGP) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOBUTANE (UNII: BXR49TP611) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-724-34 170 g in 1 CAN; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2016 Labeler - Edgewell Personal Care Brands LLC (151179769)