FDA.reportPublic FDA data

SPF30 Sunscreen Lotion and SPF15 Lip Balm

Manufacturer
Zhejiang Ayan Biotech Co.,Ltd.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:19

Label at a glance#

ProductSPF30 Sunscreen and SPF15
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure23 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 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 measure...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 10%, Octocrylene10%, 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 cancer 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



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. Sun Protection Measures.

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 AP Specialties

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
  • 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: Sun Protection Measures.

•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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2% Octocrylene 8% Octisalate 5.5% Homosalate 2%


Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

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 use and ask a doctor

OTC - STOP USE SECTION

if reash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Usa a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridencyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

Call AP Specialties

BATCH NO:

Distributed by:

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70412-231-30SPF30 Sunscreen and SPF1530 mL in 1 BOTTLELOTION30 mL100 mg in 1mL2
70412-316-07SPF30 Sunscreen and SPF152 g in 1 TUBELIPSTICK2 g20 mg in 1g2
70412-818-01SPF30 Sunscreen and SPF151 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70412-231SPF30 SUNSCREEN AND SPF15 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO.,LTD.]2Current NDC, Legacy NDC20231108_6c40259b-565a-46d0-90d0-ccc186764552.zip
70412-316SPF30 SUNSCREEN AND SPF15 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO.,LTD.]2Current NDC, Legacy NDC20231108_6c40259b-565a-46d0-90d0-ccc186764552.zip
70412-818SPF30 SUNSCREEN AND SPF15 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO.,LTD.]2Current NDC, Legacy NDC, 3 package rows20231108_6c40259b-565a-46d0-90d0-ccc186764552.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70412-81870412-818-01
70412-23170412-231-30
70412-31670412-316-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
LEVOMENOL24WE03BX2TIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
COCONUT3RT3536DHYIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYL PALMITATE2865993309IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
SHEA BUTTERK49155WL9YIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.2bb9798f-36a0-4d03-a316-8b746a9283d82024-08-26WarningsExact identifier
ndc (package): 70412-316-07
ndc (product): 70412-316
ndc11 (package): 70412031607
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.cac6f5e5-91c2-4978-bffd-5ca2a75906372023-11-06WarningsExact identifier
ndc (package): 70412-231-30
ndc (product): 70412-231
ndc11 (package): 70412023130
SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6c40259b-565a-46d0-90d0-ccc1867645522023-11-06WarningsExact identifier
ndc (package): 70412-818-01
ndc (package): 70412-316-07
ndc (package): 70412-231-30
ndc (product): 70412-818
ndc11 (package): 70412023130
ndc11 (package): 70412081801
ndc11 (package): 70412031607
spl id: 09874a42-6241-b23c-e063-6394a90a889f
spl set id: 6c40259b-565a-46d0-90d0-ccc186764552

Reported adverse events (FAERS/openFDA)#

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