SUNSCREEN

Manufacturer
Shenzhen Yikai Electronic Technology Co., Ltd.
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:11

Label at a glance#

ProductSUNSCREEN
Active ingredientOCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE
Label structure12 sections

Dosage and administration

For sunscreen use: ● apply generously 15 minutes before sun exposure ● reapply: ● after 80 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 meas...

Storage and handling

● protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%
Homosalate 15%
Octisalate 5%
Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

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

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When Using

OTC - WHEN USING SECTION

keep out of eyes. Rinse with waterto remove.

Stop Use

OTC - STOP USE SECTION

rash occurs

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:
● apply generously 15 minutes before sun exposure
● reapply:
● after 80 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 am.-2 p.m.
● wear long-sleeved shirts, pants, hats and sunglasses
● children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

● protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, polymethylsilsesquioxane, glycerin, dimethicone, poly C10-30 alkyl
acrylate, styrene/acrylates copolymer, silica, caprylyl methicone,
acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate,
PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl
phosphate, tocopherol, caprylyl glycol, panthenol, acrylates/C10-30 alkyl
acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl
carbamate, chlorphenesin, p-anisic acid, caprylic/capric triglyceride,
xanthan gum, disodium EDTA, cassia alata leaf extract, maltodextrin,
sodium dodecylbenzenesulfonate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

010102020303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83809-020-012026-01-29C16284748780-149896155-b8eb-586f-e063-e6dba90add9083809-020
83809-020-022026-01-29C16284748780-149896155-b8eb-586f-e063-e6dba90add9083809-020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83809-020-01SUNSCREEN30 mL in 1 BOTTLECREAM301
83809-020-02SUNSCREEN50 mL in 1 BOTTLECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83809-020SUNSCREEN CREAM [SHENZHEN YIKAI ELECTRONIC TECHNOLOGY CO., LTD.]12 package rows20240202_104dba3b-b740-6e26-e063-6394a90a0aa8.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83809-02083809-020-01, 83809-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
104dba3b-b741-6e26-e063-6394a90a0aa8104dba3b-b740-6e26-e063-6394a90a0aa82024-02-01WarningsExact identifier
spl id: 104dba3b-b741-6e26-e063-6394a90a0aa8
spl set id: 104dba3b-b740-6e26-e063-6394a90a0aa8

Reported adverse events (FAERS/openFDA)#

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