FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
LG H&H Co., Ltd. | fmg Co.Ltd
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:39

Label at a glance#

ProductISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN
Active ingredientZINC OXIDE
Label structure14 sections

Indications and 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

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure children under 6 months of age: ask a doctor reapply - after 40 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.52%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Do not use​on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor ifrash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • reapply
  • - after 40 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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER

QUESTIONS?

OTC - QUESTIONS SECTION

1-800-FOR-AVON

SPL UNCLASSIFIED SECTION

+ Hypoallergenic

+ Dermatologist-tested

+ Suitable for Sensitive Skin
+ PABA-Free
+ Alcohol-Free
+ Water-resistant (40 minutes)
+ Reef-friendly

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
©2023 THE AVON COMPANY

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISA KNOX

ANEW

SOLAIRE

50
SPF

EVERYDAY
MINERAL FACE

PROTECTION CREAM
BROAD SPECTRUM SPF 50 SUNSCREEN

WATER-RESISTANT (40 MINUTES)

50 ml/1.7 fl.oz. U.S.

Isa Knox Anew Solaire Everyday Mineral Face SPF50 50ml ICIsa Knox Anew Solaire Everyday Mineral Face SPF50 50ml IC

Isa Knox Anew Solaire Everyday Mineral Face SPF50 50ml ocIsa Knox Anew Solaire Everyday Mineral Face SPF50 50ml oc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-211-01ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN50 mL in 1 TUBECREAM502
53208-211-01ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN2 in 1 BOXCREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-211ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN (ZINC OXIDE) CREAM [LG H&H CO., LTD.]2Current NDC, Legacy NDC, 2 package rows20250125_f1166cb4-b471-7043-e053-2a95a90a7fa7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53208-21153208-211-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.f1166cb4-b471-7043-e053-2a95a90a7fa72025-01-01WarningsExact identifier
ndc (package): 53208-211-01
ndc (product): 53208-211
ndc11 (package): 53208021101
spl id: 2c6bd652-2ee6-b9c5-e063-6294a90aee0a
spl set id: f1166cb4-b471-7043-e053-2a95a90a7fa7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.