BANANA BOAT SIMPLY PROTECT SENSITIVE MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50- homosalate,octisalate,octocrylene,zinc oxide spray

Banana Boat simply protect sensitive MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

Banana Boat simply protect sensitive MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%

Purpose

Sunscreen

Uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

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.

Do not use

on damaged or broken skin.

When using this product

keep away from face to avoid breathing it keep out of eyes. Rinse with water to removed.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

May stain some fabrics.

Directions

Shake well 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 and 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 Children under 6 months: 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

Water, Isobutane, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Phenoxyethanol, Polyhydroxystearic acid, Triethoxycaprylylsilane, Sodium Citrate.

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT®

NEW!

simply

protect

sensitive™

MINERAL ENRICHED SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

HYPOALLERGENIC
WITH NATURALLY SOURCED ZINC

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 6 OZ. (170 g)

55%

MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

BANANA BOAT®

NEW!

simply

protect

sensitive™

MINERAL ENRICHED SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

HYPOALLERGENIC
WITH NATURALLY SOURCED ZINC

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 9.5 OZ. (269 g)

INGREDIENTS AND APPEARANCE

BANANA BOAT SIMPLY PROTECT SENSITIVE MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 
homosalate,octisalate,octocrylene,zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-261
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ISOBUTANE (UNII: BXR49TP611)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-261-34	170 g in 1 CAN; Type 0: Not a Combination Product	09/23/2019
2	NDC: 63354-261-37	269 g in 1 CAN; Type 0: Not a Combination Product	09/23/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/23/2019

Labeler - Edgewell Personal Care Brands LLC (151179769)