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NDC 13630-0254-04 24/7 life by 7-Eleven 25.11; 62.78; 41.85; 41.85 g/mL; g/mL; g/mL; g/mL Details

24/7 life by 7-Eleven 25.11; 62.78; 41.85; 41.85 g/mL; g/mL; g/mL; g/mL

24/7 life by 7-Eleven is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Prime Packaging, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	13630-0254
Product ID	13630-0254_ece8bf4d-b2a6-3a3e-e053-2995a90a334f
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	24/7 life by 7-Eleven
Proprietary Name Suffix	Broad Spectrum SPF
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	25.11; 62.78; 41.85; 41.85
Active Ingredient Units	g/mL; g/mL; g/mL; g/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Prime Packaging, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M020
Listing Certified Through	2024-12-31

Package

Package Images

NDC 13630-0254-04 (13630025404)

Pricing Information	N/A
NDC Package Code	13630-0254-4
Billing NDC	13630025404
Package	186 mL in 1 CAN (13630-0254-4)
Marketing Start Date	2022-05-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ece8ba41-2167-bf76-e053-2995a90a2855 Details

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

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.

Keep out of reach of children.

If 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

apply liberally and spread evenly by hand 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 value 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, & 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 & direct sun.

Avoid spraying on fabrics - could cause discoloration.

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

INGREDIENTS AND APPEARANCE

24/7 LIFE BY 7-ELEVEN BROAD SPECTRUM SPF

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0254
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	62.78 g in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	41.85 g in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.85 g in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.11 g in 1 mL

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

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:13630-0254-4	186 mL in 1 CAN; Type 0: Not a Combination Product	05/17/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	05/17/2022

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0254) , label(13630-0254) , analysis(13630-0254) , pack(13630-0254)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0254) , pack(13630-0254)

Revised: 11/2022

Document Id: ece8bf4d-b2a6-3a3e-e053-2995a90a334f

Set id: ece8ba41-2167-bf76-e053-2995a90a2855

Version: 1

Effective Time: 20221107