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NDC 30142-0985-15 sunscreen 90; 2250; 250; 640 g/g; g/g; g/g; g/g Details

sunscreen 90; 2250; 250; 640 g/g; g/g; g/g; g/g

sunscreen is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Kroger Co. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	30142-0985
Product ID	30142-985_14ebcdeb-214c-48f2-92fa-a67fad8cbf4d
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	sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	90; 2250; 250; 640
Active Ingredient Units	g/g; g/g; g/g; g/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Kroger Co
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0985-15 (30142098515)

Pricing Information	N/A
NDC Package Code	30142-985-15
Billing NDC	30142098515
Package	258 g in 1 CAN (30142-985-15)
Marketing Start Date	2020-07-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c5170187-8bdd-443c-b4a0-82228c8110e8 Details

claims

Kroger Kids Sunscreen Spray SPF 50 provides quick and easy coverage with broad-spectrum protection. Its clear, specially formulated spray goes on at any angle. Water-resistant formula provides protection in and out of water for up to 80 minutes.

active ingredients

Avobenzone, Homosalate, Octisalate, Octocrylene

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

Flammable

Keep away from fire or flame.

after application, wait until product dries before approacing a souce of heat or flame, or before smoking

do not use

on damaged or broken skin

SPL UNCLASSIFIED SECTION

keep out of eyes. Rinse with water to remove.  contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF.

stop use and ask a doctor if

rash occurs

keep out of reach of children

if swallowed, get medical help or contact a Poison Conrol Center right away

direction

■ spray liberally and spread evenly by hand 15 minutes before sun exposure

■ apply to all skin exposed to the sun

■ 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 and avoid inhalation

■ 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-sleeved shirts, pants, hats and sunglasses

■ children under 6 months of age: Ask a doctor

other information

protect the product in the container from excessive heat and direct sun

inactive ingredients

alcohol denat., acrylates/octylacrylamide copolymer, glycerin, triethanolamine, tocopherol, butyloctyl salicylate, fragrance

Questions or comments?

1-822-632-6900

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics of surfaces

Oxybenzone & Octinoxate free

DISTRIBUTED BY THE KORGER CO., CINCINNATI, OHIO 45202

COPPERTONE AND COPPERTONE KIDS ARE REGISTERED TRADEMARKS OF BEIERSDORF AG. BEIERSDORF AS IS NOT AFFILATED WITH

THE KORGER CO. OR THIS PRODUCT.

QUALITY GUARANTEE

800-632-6900

www.kroger.com

principal display panel

compare to COPPERTONE KIDS

see back panel

Kroger

KIDS

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

UVA/UVB protection

hypoallergenic

continuous spray

water resistant (80 minutes)

won't run into eyes

SPF 50

REEF FRIENDLY

NET WT 5.5 OZ (156 g)

INGREDIENTS AND APPEARANCE

SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-985
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	90 g in 1 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	2250 g in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	250 g in 1 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	640 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-985-14	156 g in 1 CAN; Type 0: Not a Combination Product	07/29/2020
2	NDC:30142-985-15	258 g in 1 CAN; Type 0: Not a Combination Product	07/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/29/2020

Labeler - Kroger Co (006999528)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(30142-985)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(30142-985)

Revised: 3/2022

Document Id: 14ebcdeb-214c-48f2-92fa-a67fad8cbf4d

Set id: c5170187-8bdd-443c-b4a0-82228c8110e8

Version: 10

Effective Time: 20220309

Search by Drug Name or NDC

NDC 30142-0985-15 sunscreen 90; 2250; 250; 640 g/g; g/g; g/g; g/g Details

sunscreen 90; 2250; 250; 640 g/g; g/g; g/g; g/g

Product Information

Package

Package Images

NDC 30142-0985-15 (30142098515)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c5170187-8bdd-443c-b4a0-82228c8110e8 Details

claims

active ingredients

purpose

uses

warnings

Flammable

do not use

SPL UNCLASSIFIED SECTION

stop use and ask a doctor if

keep out of reach of children

direction

other information

inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

principal display panel

INGREDIENTS AND APPEARANCE

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