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NDC 73022-0005-02 MINERAL SUNSCREEN SPF 30 for Kids and Babies 20.5 g/100g Details

MINERAL SUNSCREEN SPF 30 for Kids and Babies 20.5 g/100g

MINERAL SUNSCREEN SPF 30 for Kids and Babies is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Hush Brands Inc. The primary component is ZINC OXIDE.

Product Information

NDC	73022-0005
Product ID	73022-005_e0386adc-504d-4acc-bdff-fa4807815778
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	MINERAL SUNSCREEN SPF 30 for Kids and Babies
Proprietary Name Suffix	BOO BAMBOO
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	20.5
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	Hush Brands Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 73022-0005-02 (73022000502)

Pricing Information	N/A
NDC Package Code	73022-005-02
Billing NDC	73022000502
Package	50 g in 1 CAN (73022-005-02)
Marketing Start Date	2020-04-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e8d5a436-ae7b-4fbc-9305-689224be123d Details

Active Ingredients (w/w )

Zinc Oxide 16.5%

Purpose

Sunscreen

Use

Helps prevent sunburn. If used as directed with other skin protection measures, 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.Do not place in hot water or near radiator, stove or other sources of heat.

Do not puncture or incinerate container or store at temperature above 50°C. Contents under pressure.

Stop use and ask a doctor if rash occurs.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults, adolescents and children over 6 months of age •Spray generously and spread evenly by hand 15 minutes before sun exposure.
Hold container 4 to 6 inches from skin to apply. • Do not spray directly onto face. Spray on hands, thenapply to face.
Do not apply in windy conditions • Use in a well-ventilated area.•Avoid inhaling or exposing others to spray.
Reapply:
- after 40 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 am - 2 pm
wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun • Store at room temperature 59-86°F. May stain surfaces and fabrics.

Inactive Ingredients

Aloe Barbendensis Leaf Juice, Aqua/ Water, Bambusa Arundinacea (Bamboo) Stem Extract, Camellia Sinensis (Japanese Green Tea) Leaf Extract, Caprylic / Capric Triglyceride, Dilauryl Citrate, Ethylhexylglycerin, Gluconolactone, Glycerin, Hydrogenated Methyl Abietate, Isopropyl Palmitate, Lauryl Glucoside, Leuconostoc / Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Methylcellulose, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Polyglyceryl-4 Laurate,

Populus Tremuloides Bark Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Lauryl Glucose Carboxylate, Sodium Phytate, Sodium Stearoyl Glutamate, Sorbitan Laurate, Tocopherol, Xanthan Gum

Questions?

1-866-923-2665

Manufactured in Canada by/ Fabriqué au Canada par: Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, L6T 4H6

UPC Please recycle (+ logo) Lot # and Expiry Date jet printed on the bottom of the aerosol can

Principal Display Panel - SPF 30 Spray

boo bamboo MINERAL SUNSCREEN SPRAY for Kids & Babies

SPF 30

BROAD SPECTRUM SPF 30

UVA/UVB PROTECTION

Water/ Sweat Resistant (40 MINUTES)

Non-whitening

Optional size ranges between 1.7 oz. to 7 oz.

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF 30 FOR KIDS AND BABIES BOO BAMBOO

zinc oxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73022-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
Bambusa Bambos Stem (UNII: NRA4497HC5)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Dilauryl Citrate (UNII: 5OYS3G306B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Ethylhexylglycerin (UNII: 147D247K3P)
Gluconolactone (UNII: WQ29KQ9POT)
Glycerin (UNII: PDC6A3C0OX)
Hydrogenated Methyl Abietate (UNII: A23O709X8O)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Lauryl Glucoside (UNII: 76LN7P7UCU)
Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)
Lonicera Caprifolium Flower (UNII: 5N1WD9784U)
Lonicera Confusa Flower (UNII: 3JV904IJ0V)
Methylcellulose (15 MPA.S) (UNII: NPU9M2E6L8)
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polyglyceryl-3 Laurate (UNII: Y9ZSR39D0E)
Populus Tremuloides Bark (UNII: 5543O0CEID)
Jojoba Oil (UNII: 724GKU717M)
Sodium Lauryl Glycol Carboxylate (UNII: 8L0472VMYL)
Phytate Sodium (UNII: 88496G1ERL)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
Sorbitan Monolaurate (UNII: 6W9PS8B71J)
Tocopherol (UNII: R0ZB2556P8)
Xanthan Gum (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73022-005-01	177 g in 1 CAN; Type 0: Not a Combination Product	04/20/2020
2	NDC:73022-005-02	50 g in 1 CAN; Type 0: Not a Combination Product	04/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/20/2020

Labeler - Hush Brands Inc (259616535)

Name	Address	ID/FEI	Business Operations
Establishment
AL SUNSCREEN SPRAY</content> </paragraph> <paragraph> <content styleCode="bold">SPF 30</content> </paragraph> <paragraph>BROAD SPECTRUM SPF 30</paragraph> <paragraph>UVA/UVB PROTECTION</paragraph> <paragraph>Water/ Sweat Resistant (40 MINUTES)</paragraph> <paragraph>Non-whitening</paragraph> <paragraph>Optional size ranges between 1.7 oz. to 7 oz.</paragraph> <paragraph> <renderMultiMedia referencedObject="L5c0feb21-672d-45f1-bd9e-2ec7f43badf8"/> </paragraph></text>		252047519	MANUFACTURE(73022-005)

Revised: 4/2020

Document Id: e0386adc-504d-4acc-bdff-fa4807815778

Set id: e8d5a436-ae7b-4fbc-9305-689224be123d

Version: 1

Effective Time: 20200420