FDA.reportPublic FDA data

Chemical Sunscreen SPF50

Manufacturer
Swiss-American CDMO, LLC
Effective date
2024-05-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:13

Label at a glance#

ProductChemical Sunscreen SPF50
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure9 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. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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...

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dicaprylyl Carbhonate, Triheptanoin C13-16 Isoalkane, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Triacontanyl PVP, Phenoxyethanol, Ethylhexylglycerin, Ceterayl Alcohol, Coco-
Glucoside, Glucose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexane, Polysorbate 60, Sorbitan Isostearate.

Purpose

OTC - PURPOSE 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.

Questions

OTC - QUESTIONS SECTION

Call toll free 1-866-416-2366

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL043 Drug FactsPL043 Drug Facts

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-0043-1Chemical Sunscreen SPF5090 g in 1 BOTTLE, SPRAYSPRAY902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-0043CHEMICAL SUNSCREEN SPF50 (OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREEN) SPRAY [SWISS-AMERICAN CDMO, LLC]2Current NDC, 1 package rows20240509_50f47495-93aa-4e11-a153-d4c847a36c99.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60232-004360232-0043-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ARGAN OIL4V59G5UW9XIACT
TRIHEPTANOIN2P6O7CFW5KIACT
COCO-GLUCOSIDEICS790225BIACT
DEXTROSEIY9XDZ35W2IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
TRIACONTANYL PVP (WP-660)N0SS3Q238DIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 60CAL22UVI4MIACT

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 SPF50OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREENSwiss-American CDMO, LLC50f47495-93aa-4e11-a153-d4c847a36c992024-05-08WarningsExact identifier
ndc (package): 60232-0043-1
ndc (product): 60232-0043
ndc11 (package): 60232004301
spl id: 42c3d5f5-5ddb-4f54-9843-59d438639624
spl set id: 50f47495-93aa-4e11-a153-d4c847a36c99

Reported adverse events (FAERS/openFDA)#

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