Label: BANANA BOAT- titanium dioxide, zinc oxide lotion
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- NDC Code(s): 63354-924-21, 63354-924-24, 63354-924-26, 63354-924-27
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated June 3, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only
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.
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
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Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene,Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate,Tocopheryl Acetate.
- Other Information
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Principal Display Panel
NEW!
25% MORE
VALUE SIZE
tear free
BANANA
BOAT (R)
simply
protect (TM)
KiDS
MINERAL-BASED SUNSCREEN LOTION
50+
25% fewer ingredients*
MADE WITHOUT OXYBENZONE & PARABENS
NO ADDED OILS & FRAGRANCES
BROAD SPECTRUM SPF 50+
WATER RESISTANT (80 MINUTES)
7.5 FL. OZ. (221.8 mL)
50%
MORE
FAMILY SIZE!
9 OZ VS 6 OZ
BANANA
BOAT®
NEW
LOOK!
simply
protect™
KiDS
MINERAL BASED SUNSCREEN LOTION
UVA/UVB BROAD SPECTRUM SPF 50+
50+
25% FEWER INGREDIENTS*
MADE WITHOUT OXYBENZONE & PARABENS
tear free
No Added Oils & Fragrances
Water Resistant
(80 Minutes)
9 FL. OZ. (270 mL)
BANANA
BOAT®
NEW
LOOK!
simply
protect™
KiDS
MINERAL BASED SUNSCREEN LOTION
UVA/UVB BROAD SPECTRUM SPF 50+
50+
25% FEWER INGREDIENTS*
MADE WITHOUT OXYBENZONE & PARABENS
tear free
No Added Oils & Fragrances
Water Resistant
(80 Minutes)
1 FL. OZ. (29 mL)
BANANA
BOAT®
NEW
LOOK!
simply
protect™
KiDS
MINERAL BASED SUNSCREEN LOTION
UVA/UVB BROAD SPECTRUM SPF 50+
50+
25% FEWER INGREDIENTS*
MADE WITHOUT OXYBENZONE & PARABENS
tear free
No Added Oils & Fragrances
Water Resistant
(80 Minutes)
6 FL. OZ. (177 mL)
Tear free
Banana
Boat
simply
protect
kids
mineral based sunscreen lotion
50+
25% fewer ingredients*
made without oxybenzone & parabens
no added oils & fragrances
broad spectrum spf 50+
water resistant (80 minutes)
-
INGREDIENTS AND APPEARANCE
BANANA BOAT
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-924 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.5 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALUMINUM OXIDE (UNII: LMI26O6933) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) ISOHEXADECANE (UNII: 918X1OUF1E) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-924-21 29 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2018 2 NDC:63354-924-24 177 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2018 3 NDC:63354-924-27 270 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2018 4 NDC:63354-924-26 7.5 g in 1 TUBE; Type 0: Not a Combination Product 06/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2018 Labeler - Edgewell Personal Care Brands LLC (151179769) Establishment Name Address ID/FEI Business Operations Playtex Manufacturing Inc 963501502 manufacture(63354-924)