30 SPF by Shalom International Corp / Empack Spraytech Inc Drug Facts

30 SPF by

Drug Labeling and Warnings

30 SPF by is a Otc medication manufactured, distributed, or labeled by Shalom International Corp, Empack Spraytech Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

30 SPF JACK NICKLAUS- sunscreen aerosol, spray 
Shalom International Corp

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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Drug Facts

Active Ingredients (w/w )

Avobenzone 2%

Homosalate 15%

Octisalate 5%

Oxybenzone 4%

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 80 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

Acrylates/ Octylacrylamide Copolymer, Alcohol Denat., Aloe Barbadensis Leaf Juice, Cocos Nucifera (coconut) oil, Diethylhexyl 2,6- Naphthalate, Glycerin, Mineral Oil, Fragrance (Parfum).

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 - 30 SPF SUNSCREEN SPRAY

30 SPF SUNSCREEN SPRAY

BROAD SPECTRUM SPF 30

UVA/UVB PROTECTION

Water/ Sweat Resistant (80 MINUTES)

Net Content 177 ml/ 16 fl. oz   (159 g)

30 SPF  JACK NICKLAUS
sunscreen aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73025-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALCOHOL (UNII: 3K9958V90M)
COCONUT OIL (UNII: Q9L0O73W7L)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73025-070-01	159 g in 1 CAN; Type 0: Not a Combination Product	07/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/08/2020	06/30/2022

Labeler - Shalom International Corp (001384825)

Establishment
Name	Address	ID/FEI	Business Operations
Empack Spraytech Inc		252047519	manufacture(73025-070)

Revised: 12/2021

Document Id: d2927b7f-2867-7d96-e053-2a95a90ac18f

34390-5

Set id: 1f35b666-d68a-4334-a440-45a197e692b0

Version: 2

Effective Time: 20211207