FDA.reportPublic FDA data

Chemical Sunscreen SPF50 with Antipollution

Manufacturer
Swiss-American CDMO, LLC
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:47

Label at a glance#

ProductChemical Sunscreen SPF50 with Antipollution
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially fro...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Indications and Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 15.0% Sunscreen
Octocrylene 10.0% Sunscreen
Avobenzone 3.0% Sunscreen
Octisalate 5.0% Sunscreen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, C15-19 Alkane, Triheptanoin C13-16 Isoalkane, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Cetearyl alcohol, Coco-Glucoside, Glucose, Argania Spinosa Kernel Oil, Phenoxyethanol, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Triacontanyl PVP, Biosaccharide Gum-4, 1,2-Hexanediol

Questions

OTC - QUESTIONS SECTION

Call toll free 1-866-416-2366

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL044 Drug FactsPL044 Drug Facts

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-4400-1Chemical Sunscreen SPF50 with Antipollution28 g in 1 TUBELOTION281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-4400CHEMICAL SUNSCREEN SPF50 WITH ANTIPOLLUTION (HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREEN) LOTION [SWISS-AMERICAN CDMO, LLC]1Current NDC, 1 package rows20250427_59efb7dd-83f9-4222-9b7e-ea17ac4ece00.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60232-440060232-4400-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
C15-19 ALKANECI87N1IM01IACT
TRIHEPTANOIN2P6O7CFW5KIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
COCO-GLUCOSIDEICS790225BIACT
ARGANIA SPINOSA SEED8H7X7XB54HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
TRIACONTANYL PVP (WP-660)N0SS3Q238DIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
C13-16 ISOPARAFFINLED42LZG6OIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT

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
Chemical Sunscreen SPF50 with AntipollutionHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREENSwiss-American CDMO, LLC59efb7dd-83f9-4222-9b7e-ea17ac4ece002024-10-18WarningsExact identifier
ndc (package): 60232-4400-1
ndc (product): 60232-4400
ndc11 (package): 60232440001
spl id: 599d29ff-b8bf-4010-822c-d8c72e8adc35
spl set id: 59efb7dd-83f9-4222-9b7e-ea17ac4ece00

Reported adverse events (FAERS/openFDA)#

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