BASK BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene spray
Prime Packaging, Inc.

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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BASK Non-Aerosol Invisible Mist Sunscreen Broad Spectrum SPF 50 Continuous Spray

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 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. Keep away from face to avoid breathing it.

Stop use and ask a doctor if rash occurs

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

Flammable: Do not use near heat, flame or while smoking. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

Directions

• Shake well before use • Apply liberally 15 minutes before sun exposure and rub into skin • Hold container 4 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 80 minutes of swimming or sweating

- Immediately after towel drying

- At least every 2 hours

• 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 of 15 or higher and other sun protection measures including:

- Limit time in the sun, especially from 10 a.m. – 2 p.m.

- Wear long-sleeve shirts, pants, hats, and sunglasses

- Children under 6 months: ask a doctor before use.

Inactive ingredients

Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer.

Other information

• Protect this product from excessive heat and direct sun

• Avoid spraying on fabrics - could cause discoloration.

Questions or comments?

Call toll free 866-960-1568

BASK Non-Aerosol Invisible Mist Sunscreen Broad Spectrum SPF 50 Continuous Spray

Principle Display Label

BASK BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0243
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	83.4 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.7 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	41.7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0243-4	187 mL in 1 CAN; Type 0: Not a Combination Product	04/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	04/14/2022

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0243) , analysis(13630-0243)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0243) , pack(13630-0243)

Revised: 8/2022

Document Id: e64b24d4-ea53-4835-e053-2995a90a2c2c

Set id: e64b25af-4a7a-7cb1-e053-2995a90a5f63

Version: 1

Effective Time: 20220815

Prime Packaging, Inc.