BANANA BOAT SIMPLY PROTECT SENSITIVE MINERAL ENRICHED SUNSCREEN BROAD SPECTRUM SPF 50- homosalate,octisalate,octocrylene,zinc oxide lotion

Banana Boat simply protect sensitive Mineral Enriched Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Banana Boat simply protect sensitive Mineral Enriched Sunscreen 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 4.5%, 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.

Do not use

on damaged or broken skin

When using this product

Keep out of eyes. Rinse with water to remove.

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

Apply liberally 15 minutes before sun exposure

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 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

Children under 6 months: Ask a doctor

Inactive ingredients

Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-3 Methylglucose Distearate, VP/Eicosene Copolymer, Phenoxyethanol, Xanthan Gum, Glyceryl Stearate, PEG-100 Stearate, Beeswax, Polyhydroxystearic acid, Chlorphenesin, Triethoxycaprylylsilane, Disodium EDTA

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

50%

MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT®

NEW!

simply

protect

sensitive™

MINERAL ENRICHED# SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

HYPOALLERGENIC

No Added Oils & Fragrances

Water Resistant

(80 Minutes)

9 FL. OZ. (270 mL)

BANANA

BOAT®

simply

protect

sensitive™

MINERAL ENRICHED# SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

HYPOALLERGENIC

No Added Oils & Fragrances

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT SIMPLY PROTECT SENSITIVE MINERAL ENRICHED SUNSCREEN BROAD SPECTRUM SPF 50 
homosalate,octisalate,octocrylene,zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-770
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.395 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-770-24	170 g in 1 TUBE; Type 0: Not a Combination Product	11/18/2019
2	NDC: 63354-770-27	255 g in 1 TUBE; Type 0: Not a Combination Product	11/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/18/2019

Labeler - Edgewell Personal Care Brands LLC (151179769)