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NDC 69435-1503-01 Botao Baby Mineral Foam 24 g/96g Details

Botao Baby Mineral Foam 24 g/96g

Botao Baby Mineral Foam is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Peer Pharm Ltd.. The primary component is ZINC OXIDE.

Product Information

NDC	69435-1503
Product ID	69435-1503_e1562f60-8048-4392-e053-2a95a90a8968
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Botao Baby Mineral Foam
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	24
Active Ingredient Units	g/96g
Substance Name	ZINC OXIDE
Labeler Name	Peer Pharm Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69435-1503-01 (69435150301)

Pricing Information	N/A
NDC Package Code	69435-1503-1
Billing NDC	69435150301
Package	96 g in 1 BOTTLE, SPRAY (69435-1503-1)
Marketing Start Date	2022-05-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e1562f60-8047-4392-e053-2a95a90a8968 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/19/2022

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

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

Revised: 6/2022

Document Id: e1562f60-8048-4392-e053-2a95a90a8968

Set id: e1562f60-8047-4392-e053-2a95a90a8968

Version: 1

Effective Time: 20220613