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NDC 30142-0889-37 KROGER KIDS SPF 50 SUNSCREEN 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g Details

KROGER KIDS SPF 50 SUNSCREEN 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g

KROGER KIDS SPF 50 SUNSCREEN is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by THE KROGER COMPANY. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	30142-0889
Product ID	30142-889_a4fd9c0a-b6f4-e2da-e053-2a95a90aacbf
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	KROGER KIDS SPF 50 SUNSCREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 40; 50
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	THE KROGER COMPANY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0889-37 (30142088937)

Pricing Information	N/A
NDC Package Code	30142-889-37
Billing NDC	30142088937
Package	156 g in 1 CAN (30142-889-37)
Marketing Start Date	2017-11-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a4fd9c0a-b6f3-e2da-e053-2a95a90aacbf Details

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 5.0%

Purpose

Sunscreen

SPL UNCLASSIFIED SECTION

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:

do not use near heat, flame or while smoking
avoid long term storage above 104ºF (40ºC)

SPL UNCLASSIFIED SECTION

Do not use

on damaged or broken skin.

SPL UNCLASSIFIED SECTION

When using this product

keep out of eyes. Rinse with water to remove.
keep away from face to avoid breathing it
do not puncture or incinerate. Contents under pressure.
do not store at temperatures above 120º F.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

rash occurs.

SPL UNCLASSIFIED SECTION

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

Directions

spray liberally and spread evenly by hand 15 minutes before sun exposure
hold can 4 to 6 inches away from skin to apply
do not spray directly into face. Spray into hand 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
children under 6 months of age: 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 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

Other information

protect this product from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

Inactive ingredients

alcohol denat. (73.2% v.v), acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride

Questions or comments?

1-800-632-6900

PRINCIPAL DISPLAY PANEL

KROGER KIDS SPF 50 SUNSCREEN CONTINUOUS SPRAY

INGREDIENTS AND APPEARANCE

KROGER KIDS SPF 50 SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-889
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-889-37	156 g in 1 CAN; Type 0: Not a Combination Product	11/02/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/02/2017

Labeler - THE KROGER COMPANY (006999528)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Name	Address	ID/FEI	Business Operations
Establishment
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(30142-889)

Revised: 5/2020

Document Id: a4fd9c0a-b6f4-e2da-e053-2a95a90aacbf

Set id: a4fd9c0a-b6f3-e2da-e053-2a95a90aacbf

Version: 1

Effective Time: 20200506

Search by Drug Name or NDC

NDC 30142-0889-37 KROGER KIDS SPF 50 SUNSCREEN 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g Details

KROGER KIDS SPF 50 SUNSCREEN 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 30142-0889-37 (30142088937)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a4fd9c0a-b6f3-e2da-e053-2a95a90aacbf Details

Active ingredients

Purpose

SPL UNCLASSIFIED SECTION

Warnings

FLAMMABLE:

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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