FDA.reportPublic FDA data

Private Label SPF45 Water Resistant Paraben Free Sunscreen

Manufacturer
Swiss-American CDMO, LLC
Effective date
2023-11-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:38

Label at a glance#

ProductPrivate Label SPF45 Water Resistant Paraben Free Sunscreen
Active ingredientZINC OXIDE, OCTINOXATE, OCTISALATE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (See Directions), decrease 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 th...

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 physician if rash occurs. Keep out of reach of children. 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 measures (See Directions), decrease 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 measures (See Directions), decrease 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 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 a.m. – 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

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

Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ascorbyl Palmitate, Butylene Glycol, Cylcopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isonnonanoate, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethyoxycaprylylsilane

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL006 ArtworkPL006 Artwork

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60232-0006-1Private Label SPF45 Water Resistant Paraben Free Sunscreen50 g in 1 BOTTLELOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-0006PRIVATE LABEL SPF45 WATER RESISTANT PARABEN FREE SUNSCREEN (OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN) LOTION [SWISS-AMERICAN CDMO, LLC]3Current NDC, Legacy NDC, 1 package rows20231109_f997f4fc-7da5-433c-9a53-2030b489b4f6.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60232-000660232-0006-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
VITAMIN A PALMITATE1D1K0N0VVCIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT

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 SPF45 Water Resistant Paraben Free SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCf997f4fc-7da5-433c-9a53-2030b489b4f62023-11-07WarningsExact identifier
ndc (package): 60232-0006-1
ndc (product): 60232-0006
ndc11 (package): 60232000601
spl id: 21e18883-f579-425a-a460-1e601e1b30be
spl set id: f997f4fc-7da5-433c-9a53-2030b489b4f6

Reported adverse events (FAERS/openFDA)#

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