BOTAO BABY MINERAL FOAM- zinc oxide lotion

Botao Baby Mineral Foam by

Drug Labeling and Warnings

Botao Baby Mineral Foam by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients(in each 30 ml)

Zinc Oxide 24.5%

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 or irritation develops and lasts.

Keep out of reach of children.

If swallowed, call a poison control center or get medical help right  away.

Directions

shake well before each use

spray liberally and spread evenly by hand 15 minutes before sun exposure

hold4 to 6 inches from the skin to apply

do not spray directly into face.

Spray on hands then apply to face

do not apply in windy conditions

Use in a well-ventilated area

reapply: after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Inactive Ingredients

Water,Coco-Caprylate, Styrene/Acrylates Copolymer,Butane,Isobutane, Propane, Octlydodecyl Citrate Crosspolymer,Cetearyl Olivate, Sorbitan Olivate, Caprylyl Glycol, Glycerin, Polyhydroxystearic acid, Aloe Barbadensis Leaf Juice, Panthenol, Triethoxycapryllsilane, Cetearyl Alcohol,Tocopherol, Butyrosperum Parkii (Shea) Butter,Silica, Silica Dimethyl Silyate , Xanthan Gum, Caprylhydroxamix Acid, Propanediol, Sodium Phytate, Dipotassium Glycyrrhizate, Chamomilla Recutita, (Matricaria) Flower Extract ,Calendula Officianlis Flower Extract,Citric Acid

Other Information

• Store in room temparture
• protect from freezing
• may stain clothing

Package Labeling

INGREDIENTS AND APPEARANCE

BOTAO BABY MINERAL FOAM 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 96 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID ISOPROPYL ETHER (UNII: 19776V0481)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE (UNII: 4828G836N6)
SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L)
ISOBUTANE (UNII: BXR49TP611)
WATER (UNII: 059QF0KO0R)
1-(ETHYLTRISULFANYL)PROPANE (UNII: 4SOS6O9G2X)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL 1-PHOSPHATE (UNII: 48G71659RB)
CHAMOMILE (UNII: FGL3685T2X)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE (UNII: V5VD430YW9)
1,4-BUTANEDITHIOL (UNII: 7JD227IUMC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1503-1	96 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/19/2022

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm Ltd.		514678390	manufacture(69435-1503)