MINERAL SUNSCREEN SPF 30 FOR KIDS AND BABIES BOO BAMBOO- zinc oxide aerosol, spray

MINERAL SUNSCREEN SPF 30 for Kids and Babies by

Drug Labeling and Warnings

MINERAL SUNSCREEN SPF 30 for Kids and Babies by is a Otc medication manufactured, distributed, or labeled by Hush Brands Inc, AL SUNSCREEN SPRAY 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. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/20/2020

Labeler - Hush Brands Inc (259616535)

Establishment
Name	Address	ID/FEI	Business Operations
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)