FDA.reportPublic FDA data

Sunscreen

Manufacturer
NingBo Huize Commodity Co.,Ltd.
Effective date
2018-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:19

Label at a glance#

ProductSunscreen
Active ingredientOXYBENZONE, OCTISALATE, OCTINOXATE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%,Octisalate 2.0%,Oxybenzone 4.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

WARNINGS:

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This products has been shown only to prevent sunburn, not skin cancer or early skin aging. 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. Stop use and ask a doctor if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Stearic acid , Hexadecan-1-ol, Lanolin , Mineral oil, Glyceryl Stearate, POLYSORBATE80, Sorbitan Stearate,Glycerin,DMDM Hydantoin,Frangrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71011-004-012020-01-31C16284748780-19d75b9d0-8f7d-f424-e053-dadaa90a57ce71011-004 sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71011-004-01Sunscreen30 g in 1 BOTTLELOTION301
71011-004-01Sunscreen100 in 1 BOXLOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71011-004SUNSCREEN (OXYBENZONE,OCTINOXATE,OCTISALATE) LOTION [NINGBO HUIZE COMMODITY CO.,LTD.]1Legacy NDC, 2 package rows20180718_713f3bf5-ee59-516a-e053-2995a90a811c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71011-00471011-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
OXYBENZONE95OOS7VE0YACTIB
LANOLIN7EV65EAW6HIACT
DMDM HYDANTOINBYR0546TOWIACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
HEXADECANALWQD27655QEIACT
MINERAL OILT5L8T28FGPIACT
OCTINOXATE4Y5P7MUD51ACTIB

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
713f3bf5-ee5a-516a-e053-2995a90a811c713f3bf5-ee59-516a-e053-2995a90a811c2018-07-18WarningsExact identifier
spl id: 713f3bf5-ee5a-516a-e053-2995a90a811c
spl set id: 713f3bf5-ee59-516a-e053-2995a90a811c

Reported adverse events (FAERS/openFDA)#

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