ANTIPERSPIRANT ABOVE ELEMENTS OCEAN- antiperspirant above elements ocean aerosol aerosol, spray
Baston Indústria de Aerossóis Ltda

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.

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Antiperspirant Above Elements Ocean Aerosol

Aluminum sesquichlorohydrate 24%

Antiperspirant

Uses - reduces underarm wetness

apply to underarms only

BUTANE/PROPANE/ ISOBUTANE /ALUMINUM SESQUICHLOROHYDRATE/ CYCLOPENTASILOXANE/DIMETHICONE/ISOPROPYL MYRISTATE/C12-15 ALKYL BENZOATE/PARFUM/QUARTENIUM-18 HECTORITE/PROPYLENE CARBONATE/CYCLOHEXASILOXANE/SILICA/TOCOPHERYL ACETATE/GOSSYPIUM HERBACEUM SEED OIL/DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER/GLYCINE SOJA OIL/ALLANTOIN/BUTYROSPERMUM PARKII BUTTER/MACADAMIA TERNIFOLIA SEED OIL/
COCOS NUCIFERA FRUIT EXTRACT/CHAMOMILA RECUTITA FLOWER EXTRACT/ ALOE BARBADENSIS LEAF EXTRACT/CAMELLIA SINENSIS LEAF EXTRACT/CINNAMOMUM ZEYLANICUM BARK EXTRACT/ACORUS CALAMUS ROOT EXTRACT/COMMIPHORA MYRRHA RESIN EXTRACT/OLEA EUROPAEA FRUIT OIL/PERSEA GRATISSIMA OIL/ARGANIA SPINOSA KERNEL OIL/LECITHIN/ POLYGLYCERYL-3 DIISOSTEARATE/GLYCERIN/GLYCERYL STEARATE/CYCLOTETRASILOXANE/AQUA.

e-mail: sac @baston.com.br or call: +1(305)677-5030

•Keep Out Of Reach Of Children

•Flammable until fully dry. Do not use near heat, Flame or while smoking. Can cause serious injury or deat•Keep away from face and mouth to avoid breathing in•Avoid spraying in eyes•Contents under pressure•Do not puncture or incinerate•Do not expose to heat or store at temperatures above 120 ºF/50 ºC or in enclosed places that could overheat•Do not use on broken skin•Stop use if rash or irritation occurs•Ask a doctor before using if you have kidney disease•USE ONLY AS DIRECTED•INTENTIONAL MISUSE BY DELIBERATELY CONCENTRATING AND INHALING THE CONTENTS CAN BE HARMFUL OR FATAL•Avoid de inhalation of the product.

PACKAGE LABEL

ANTIPERSPIRANT ABOVE ELEMENTS OCEAN
antiperspirant above elements ocean aerosol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73306-1117
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V)	ALUMINUM SESQUICHLOROHYDRATE	24 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
PROPANE (UNII: T75W9911L6)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CINNAMON BARK OIL (UNII: XE54U569EC)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
ALLANTOIN (UNII: 344S277G0Z)
BUTANE (UNII: 6LV4FOR43R)
CHAMOMILE (UNII: FGL3685T2X)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AVOCADO OIL (UNII: 6VNO72PFC1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MACADAMIA OIL (UNII: 515610SU8C)
SHEA BUTTER (UNII: K49155WL9Y)
MYRRH OIL (UNII: H74221J5J4)
LEVANT COTTON SEED (UNII: 550E4N439V)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
COCONUT (UNII: 3RT3536DHY)

Product Characteristics
Color	yellow (yellowish to Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73306-1117-1	90 g in 1 CAN; Type 0: Not a Combination Product	09/17/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	09/17/2019

Labeler - Baston Indústria de Aerossóis Ltda (897727605)

Registrant - Baston Indústria de Aerossóis Ltda (897727605)

Name	Address	ID/FEI	Business Operations
Establishment
Baston Indústria de Aerossóis Ltda		897727605	manufacture(73306-1117)