FDA.reportPublic FDA data

SPF30 Sunscreen Lotion

Manufacturer
Zhejiang Ayan Biotech Co., Ltd.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:02:50

Label at a glance#

ProductSPF30 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure9 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 your 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 p...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

​Avobenzone 3%,

Homostate 10%,

Octocrylene 10%,

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

WARNINGS:

WARNINGS SECTION

Spending time in the sun increases your risk of skin cnacer or early skin aging.  this product has been shown only to prevent sunburn skin cancer or early skin aging. this product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT

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 your 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

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other information

SPL UNCLASSIFIED SECTION

• Protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

Call toll free

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20mL20mL

15mL15mL

30mL30mL

45mL45mL

53mL53mL

60mL60mL

SPL UNCLASSIFIED SECTION

Package Labeling: (35mL 70412-231-35)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70412-231-15SPF30 Sunscreen15 mL in 1 BOTTLELOTION155
70412-231-20SPF30 Sunscreen20 mL in 1 BOTTLELOTION205
70412-231-30SPF30 Sunscreen30 mL in 1 BOTTLELOTION305
70412-231-35SPF30 Sunscreen35 mL in 1 BOTTLELOTION355
70412-231-45SPF30 Sunscreen45 mL in 1 BOTTLELOTION455
70412-231-53SPF30 Sunscreen53 mL in 1 BOTTLELOTION535
70412-231-60SPF30 Sunscreen60 mL in 1 BOTTLELOTION605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70412-231SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATE) LOTION [ZHEJIANG AYAN BIOTECH CO., LTD.]5Current NDC, Legacy NDC, 7 package rows20231129_cac6f5e5-91c2-4978-bffd-5ca2a7590637.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70412-23170412-231-15, 70412-231-60, 70412-231-45, 70412-231-53, 70412-231-30, 70412-231-35, 70412-231-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
LEVOMENOL24WE03BX2TIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
COCONUT3RT3536DHYIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.cac6f5e5-91c2-4978-bffd-5ca2a75906372023-11-06WarningsExact identifier
ndc (package): 70412-231-45
ndc (package): 70412-231-20
ndc (package): 70412-231-15
ndc (package): 70412-231-53
ndc (package): 70412-231-60
ndc (package): 70412-231-35
ndc (package): 70412-231-30
ndc (product): 70412-231
ndc11 (package): 70412023115
ndc11 (package): 70412023135
ndc11 (package): 70412023130
ndc11 (package): 70412023160
ndc11 (package): 70412023120
ndc11 (package): 70412023153
ndc11 (package): 70412023145
spl id: 098708e4-06f3-7b7e-e063-6294a90ad447
spl set id: cac6f5e5-91c2-4978-bffd-5ca2a7590637
SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6c40259b-565a-46d0-90d0-ccc1867645522023-11-06WarningsExact identifier
ndc (package): 70412-231-30
ndc11 (package): 70412023130

Reported adverse events (FAERS/openFDA)#

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