FDA.reportPublic FDA data

Sunscreen

Manufacturer
Zhejiang Ayan Biotech Co.,Ltd.
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:48:26

Label at a glance#

ProductSunscreen
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

•Helps prevent sunburn

Dosage and administration

Non-Water Resistant Product •Apply liberally 15 minutes before sun exposure •Use a water resistant sunscreen if swimming or sweating •Reapply at least every 2 hours •Children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other su...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 2.0%

Oxybenzone 4.0%

Titanium Dioxide 2.5%

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 increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn NOT skin cancer or early skin aging. This product is NOT water resistant or sweat resistant.

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 use and ask a doctor

OTC - STOP USE SECTION

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 Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Non-Water Resistant Product
•Apply liberally 15 minutes before sun exposure
•Use a water resistant sunscreen if swimming or sweating
•Reapply at least every 2 hours
•Children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
•Limit time in the sun, especially from 10 a.m. to 2 p.m.

•Wear long sleeve shirts, pants, hats and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Ceteareth-25, Cetearyl Alcohol, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Myristyl Propionate, PEG-15 Cocomonium Chloride, PEG-9 Dimethicone, Propylene Glycol Dioleate,Water, Xanthan Gum.

Other information

SPL UNCLASSIFIED SECTION

• Protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free

​Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70412-23070412-230-15, 70412-230-30, 70412-230-45, 70412-230-53, 70412-230-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETEARETH-258FA93U5T67IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MYRISTYL PROPIONATEP59053E7NJIACT
PEG-9 DIMETHICONE (400 CST)9OZ27X065DIACT
PROPYLENE GLYCOL DIOLEATE84T0LSN7U6IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
9a9d41b8-9fdd-f8e7-e053-2995a90a8bf496f97a4c-514b-4f23-b5bb-294b733620892019-12-26WarningsExact identifier
spl id: 9a9d41b8-9fdd-f8e7-e053-2995a90a8bf4
spl set id: 96f97a4c-514b-4f23-b5bb-294b73362089

Reported adverse events (FAERS/openFDA)#

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