Ultimate Sheer SPF 55 body

Manufacturer
TopCo | Product Quest Mfg
Effective date
2018-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:17

Label at a glance#

ProductUltimate Sheer SPF 55 body
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Label structure9 sections

Dosage and administration

• spray liberally and spread evenly by hand 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • hold container 4 to 6 inches from the skin to apply • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in a well-ventilated area • Sun Protection Measures. Spending tim...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose
Avobenzone 3.00%, Homosalate 15.00%,
Octisalate 5.00%, Octocrylene 2.75%,
Oxybenzone 6.00%.

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Uses • helps prevent sunburn

WARNINGS SECTION

Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking.
Do not use on damaged or broken skin
When using this product • Keep out of eyes. Rinse eyes with water
to remove. • Keep away from face to avoid breathing it • Do not
puncture or incinerate. Contents under pressure. Do not store at
temperatures above 120ºF.
Stop use and ask a doctor if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical
help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION


• spray liberally and spread evenly by hand 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours
• hold container 4 to 6 inches from the skin to apply • do not spray directly
into face. Spray on hands then apply to face. • do not apply in windy
conditions • use in a well-ventilated area
• 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
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

Acrylates Dimethicone Copolymer,
Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Ascorbyl Palmitate,
Cyclopentasiloxane, Dimethicone, Fragrance,
Polyester-8, PPG-5-Ceteth-20, Retinyl Palmitate,
Tocopheryl Acetate, Trisiloxane.

OTHER SAFETY INFORMATION

Other information • protect this product from excessive heat and direct sun • may stain fabrics

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-722-042020-01-31C16284748780-19d75b9d0-bab2-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-722-04Ultimate Sheer SPF 55 body141 g in 1 CANSPRAY1411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-722ULTIMATE SHEER SPF 55 BODY (AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 2.75% OXYBENZONE 6.00%) SPRAY [TOPCO]1Legacy NDC, 1 package rows20180716_5a9c2f6d-1be4-47a8-9825-58f8a6b1ec0b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-72236800-722-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
ade38f06-0008-4d35-acaf-f812b2e3b7905a9c2f6d-1be4-47a8-9825-58f8a6b1ec0b2018-07-13WarningsExact identifier
spl id: ade38f06-0008-4d35-acaf-f812b2e3b790
spl set id: 5a9c2f6d-1be4-47a8-9825-58f8a6b1ec0b

Reported adverse events (FAERS/openFDA)#

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