FDA.reportPublic FDA data

SPF 50 Stay Put Sunscreen

Manufacturer
Sawyer Products
Effective date
2016-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:38

Label at a glance#

ProductSPF 50 Stay Put Sunscreen
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
Label structure7 sections

Indications and uses

· Helps prevent sunburn.

Dosage and administration

· Apply liberally to cool, dry skin 15 minutes before sun exposure. · Use a water resistant sunscreen if swimming or sweating. · Reapply at least every 2 hours. · For children under 6 months of age: ask a doctor before using.

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 6.0%, Titanium Dioxide 2.6%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

· Helps prevent sunburn.

Warnings:

WARNINGS SECTION

​Skin Cancer/ Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.​

  • ​For external use only

Do not use

OTC - DO NOT USE SECTION

on broken or damaged skin.

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.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with warm water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Directions:

DOSAGE & ADMINISTRATION SECTION

· Apply liberally to cool, dry skin 15 minutes before sun exposure.
· Use a water resistant sunscreen if swimming or sweating.
· Reapply at least every 2 hours.
· For children under 6 months of age: ask a doctor before using.

Other information:

SPL UNCLASSIFIED SECTION

· Protect this product container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Dicaprylyl Maleate, Neopentyl Glycol Diethylhexanoate (and) Neopentyl Glycol Diisostearate, Octyldodecyl  Neopentanoate, PEG-30 Dipolyhydroxystearate, Phenoxyethanol (and) Methyl paraben (and) Ethylparaben (and) Butylparaben (and) Propyl paraben (and) Isobutylparaben, Poly ethylene, Poly quaternium 37 (and) Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6, Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterOuterInnerInner

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70392-014-012020-01-31C16284748780-19d75b9d0-acd5-f424-e053-dadaa90a57ceSPF 50 Stay Put Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70392-014-01SPF 50 Stay Put Sunscreen1 in 1 CARTONLOTION12
70392-014-01SPF 50 Stay Put Sunscreen59 mL in 1 BOTTLELOTION592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70392-014SPF 50 STAY PUT SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LOTION [SAWYER PRODUCTS]2Legacy NDC, 2 package rows20160116_dbc94b96-69f0-4636-a629-e920eebe93c5.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70392-01470392-014-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
DIOCTYL MALEATEOD88G8439LIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
NEOPENTYL GLYCOL DIISOSTEARATE4M6OQ34JWWIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
BUTYLPARABEN3QPI1U3FV8IACT
PROPYLPARABENZ8IX2SC1OHIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
PROPYLENE GLYCOL DICAPRYLATE581437HWX2IACT
PROPYLENE GLYCOL DICAPRATEU783H9JHWYIACT
PPG-1 TRIDECETH-61K7417JX6QIACT
WATER059QF0KO0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
2963172a-1d8b-20e5-e054-00144ff88e88dbc94b96-69f0-4636-a629-e920eebe93c52016-01-15WarningsExact identifier
spl id: 2963172a-1d8b-20e5-e054-00144ff88e88
spl set id: dbc94b96-69f0-4636-a629-e920eebe93c5

Reported adverse events (FAERS/openFDA)#

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