7-ELEVEN BROAD SPECTRUM SPF- avobenzone, homosalate, octisalate, octocrylene spray

7-Eleven by

Drug Labeling and Warnings

7-Eleven by is a Otc medication manufactured, distributed, or labeled by Prime Packaging, Inc., Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

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.

Keep out of reach of children.

If product is swallowed, 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 120ºF.

Directions

• shake well before use
• Spray liberally 15 minutes before sun exposure
• 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

Inactive Ingredients

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

Other Information

• Protect this product from excessive heat and direct sun.
• Avoid spraying on fabrics - could cause discoloration.

24/7 by 7-Eleven Sunscreen Spray Broad Spectrum SPF 30

INGREDIENTS AND APPEARANCE

7-ELEVEN  BROAD SPECTRUM SPF
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	62.1 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	41.4 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.4 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24.8 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0239-4	188 mL in 1 CAN; Type 0: Not a Combination Product	06/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	06/20/2022

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0239) , label(13630-0239) , analysis(13630-0239) , pack(13630-0239)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0239) , pack(13630-0239)