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NDC 72330-0502-01 ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN 2.7; 9; 4.5; 9 g/50mL; g/50mL; g/50mL; g/50mL Details

ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN 2.7; 9; 4.5; 9 g/50mL; g/50mL; g/50mL; g/50mL

ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by fmg Co.Ltd. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	72330-0502
Product ID	72330-502_d6de8140-29cd-efd1-e053-2a95a90ab393
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	ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	2.7; 9; 4.5; 9
Active Ingredient Units	g/50mL; g/50mL; g/50mL; g/50mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	fmg Co.Ltd
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 72330-0502-01 (72330050201)

Pricing Information	N/A
NDC Package Code	72330-502-01
Billing NDC	72330050201
Package	2 TUBE in 1 BOX (72330-502-01) / 80 mL in 1 TUBE
Marketing Start Date	2022-01-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d6de8135-3c70-2036-e053-2995a90a040b Details

ACTIVE INGREDIENTS

Avobenzone 2.7%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

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

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.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if rash occurs.

SPL UNCLASSIFIED SECTION

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

DIRECTIONS

For sunscreen use:

Shake well before use.
apply liberally 15 minutes before sun exposure
children under 6 months of age: ask a doctor
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
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

INACTIVE INGREDIENTS

WATER, GLYCERIN,

OTHER INFORMATION

protect the product in this container from excessive heat and direct sun
the product may stain certain types of fabrics

QUESTIONS?

1-800-FOR-AVON

SPL UNCLASSIFIED SECTION

+ Hypoallergenic

+ Dermatologist-tested

+ PABA-Free

+ Alcohol-Free

+ Suitable for Sensitive Skin

To order, contact your Avon

Indenpendent Sales Representative

or call: 1-800-FOR-AVON

www.avon.com

MADE IN KOREA

DISTR. THE AVON COMPANY,

NEW YORK, NY 10006

©2022 THE AVON COMPANY

PRINCIPAL DISPLAY PANEL

ISA KNOX

ANEW

SOLAIRE

50

SPF

ACTIVE FACE & BODY

PROTECTION LOTION

BROAD SPECTRUM SPF 50 SUNSCREEN

80 ml/2.7 fl.oz.

INGREDIENTS AND APPEARANCE

ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72330-502
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72330-502-01	2 in 1 BOX	01/31/2022
1		80 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/31/2022

Labeler - fmg Co.Ltd (690188305)

Registrant - LG HOUSEHOLD & HEALTH CARE LTD (688276187)

Name	Address	ID/FEI	Business Operations
Establishment
fmg Co.Ltd		690188305	manufacture(72330-502)

Revised: 1/2022

Document Id: d6de8140-29cd-efd1-e053-2a95a90ab393

Set id: d6de8135-3c70-2036-e053-2995a90a040b

Version: 1

Effective Time: 20220131

Search by Drug Name or NDC

NDC 72330-0502-01 ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN 2.7; 9; 4.5; 9 g/50mL; g/50mL; g/50mL; g/50mL Details

ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN 2.7; 9; 4.5; 9 g/50mL; g/50mL; g/50mL; g/50mL

Product Information

Package

Package Images

NDC 72330-0502-01 (72330050201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d6de8135-3c70-2036-e053-2995a90a040b Details

ACTIVE INGREDIENTS

PURPOSE

USES

WARNINGS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DIRECTIONS

INACTIVE INGREDIENTS

OTHER INFORMATION

QUESTIONS?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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