FDA.reportPublic FDA data

Sunscreen Emulsion SPF50plus

Manufacturer
Guangzhou Senmai Biotechnology Co. | Dongguan Xiaogoubeige trading company Ltd.
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:20

Label at a glance#

ProductSunscreen Emulsion SPF50plus
Active ingredientOCTISALATE, OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE
Label structure18 sections

Indications and uses

Helps prevent sunburn lf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 10%
Ethylhexyl Methoxycirnnamate 10%

Titanium Dioxide 8%
Ethylhexyl Salicylate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn
lf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove. Stop and ask a doctor if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Conirol Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours

Precautions

PRECAUTIONS SECTION

Spending timein the sun increasesyour risk ofskin cancer and early skin aging.Todecrease this risk, regularly use a sunscreen with abroad spectrum value of SPF 15 or higher and othersun protection measures including: limit time in thsun,especially from 10 a.m.-2 p.m.wearlong-sleeved shirts, pants, hats, and sunglasses.Children under 6 months of age: Ask a physician.

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

Product Name

DESCRIPTION SECTION

Sunscreen Emulsion SPF50plus

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Dicaprylyl Carbonate, Isononyllsononanoate, Caprylic/capric Triglyceride, Dimethicone, Ceryl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Phenyl Trimethicone,Cyclopentasiloxane,Corn Gluten Amino Acids, Magnesium Stearate,Magnesium Sulfate,Tocopheryl Acetate, Quaternium-18Bentonite, Hydroxyacetophenone, 1,2-hexanediol, Aluminum Hydroxide, Stearic Acid,
Disteardimonium Hectorite,Fragrance,Propylene Carbonate,BHT,Vitamin E

Manufacturer

DESCRIPTION SECTION

Guangzhou Senmai Biotechnology Co.

Address

DESCRIPTION SECTION

20-1second floor, 20-2 first to third floor,Dashan Road,Qinghu,Junhe Street, Baiyun district, Guangzhou City, China.

Capacity

DESCRIPTION SECTION

30ml/1.05 Fl.oz

Shelf Life

DESCRIPTION SECTION

3 Years

Place of Origin

DESCRIPTION SECTION

Made in China

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84509-002-01Sunscreen Emulsion SPF50plus30 mL in 1 BOTTLELOTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84509-002SUNSCREEN EMULSION SPF50PLUS (OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE) LOTION [GUANGZHOU SENMAI BIOTECHNOLOGY CO.]3Current NDC, 1 package rows20250110_1d560670-026b-bd34-e063-6394a90a9af4.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84509-00284509-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINO ACIDS, CORN GLUTEN0540V8ZD7VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
FRAGRANCE 135765EM498GW35IACT
PROPYLENE CARBONATE8D08K3S51EIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
OCTISALATE4X49Y0596WACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
CYCLOMETHICONE 50THT5PCI0RIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
MAGNESIUM STEARATE70097M6I30IACT
BENTOQUATAM7F465U79Q1IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

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
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
ndc (package): 84509-002-01
ndc (product): 84509-002
ndc11 (package): 84509000201
spl id: 2b3ecbec-979d-d07c-e063-6294a90a717a
spl set id: 1d560670-026b-bd34-e063-6394a90a9af4

Reported adverse events (FAERS/openFDA)#

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