FDA.reportPublic FDA data

Private Label SPF 50 80 min Water Resistant

Manufacturer
Swiss-American CDMO, LLC
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:02

Label at a glance#

ProductPrivate Label SPF 50 80 min Water Resistant
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
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. Reapply after 80 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.

Uses

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.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN   

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10.0% Sunscreen
Octisalate 5.0%
Zinc Oxide 16.5% Sunscreen

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply after 80 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.

Other safety information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

C15-19 Alkane, Calcium gluconate, citric acid, dimethicone, disodium EDTA, disteardimonium hectorite, ethylhexylglycerin, gluconolactone, Gossypium hirsutum (cotton) extract, glycerin, glyceryl behenate, hydrogenated polyisobutene, lecithin, octyldodecyl neopentanoate, phenoxyethanol, polyglyercyl-2 isostearate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, polysilicone-11, pullulan, saccharide isomerate, sclerotium gum, silica, sodium benzoate, sodium chloride, sodium citrate, sodium hydroxide, sodium olivate, tocopherol, tocopheryl acetate, triethoxycaprylysilane, xanthan gum, water

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-866-416-2366

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

B-PL035 ArtworkB-PL035 Artwork

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-0035-1Private Label SPF 50 80 min Water Resistant1000 g in 1 TUBECREAM10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-0035PRIVATE LABEL SPF 50 80 MIN WATER RESISTANT (HOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREEN) CREAM [SWISS-AMERICAN CDMO, LLC]4Current NDC, 1 package rows20231115_8849fa88-24c8-410d-b16e-60da38288f98.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60232-003560232-0035-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
C15-19 ALKANECI87N1IM01IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SORBITAN OLIVATEMDL271E3GRIACT
DIMETHICONE92RU3N3Y1OIACT
TOCOPHEROLR0ZB2556P8IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLYGLYCERYL-2 ISOSTEARATE7B8OE71MQCIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM BENZOATEOJ245FE5EUIACT
CALCIUM GLUCONATESQE6VB453KIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
GOSSYPIUM HIRSUTUM LEAF7S4U9R5259IACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PULLULAN8ZQ0AYU1TTIACT
BETASIZOFIRAN2X51AD1X3TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT

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
Private Label SPF 50 80 min Water ResistantHOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC8849fa88-24c8-410d-b16e-60da38288f982023-11-14WarningsExact identifier
ndc (package): 60232-0035-1
ndc (product): 60232-0035
ndc11 (package): 60232003501
spl id: 6a3535ae-574f-48d8-bfc0-5b38f54c93ee
spl set id: 8849fa88-24c8-410d-b16e-60da38288f98

Reported adverse events (FAERS/openFDA)#

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