FDA.reportPublic FDA data

Ultimate Sheer SPF 70

Manufacturer
Top Care | Product Quiest Mfg
Effective date
2018-07-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:20

Label at a glance#

ProductUltimate Sheer SPF 70
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                     Purpose
Avobenzone-3%
Homosalate-15%                                      Sunscreen
Octisalate-5%
Octocrylene-10%
Oxybenzone-3%

INDICATIONS & USAGE SECTION

Uses Helps prevent sunburn

WARNINGS SECTION

Warnings 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 doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Remove cap and twist up tube.
See important warnings under "When using this
product" • apply liberally 15 minutes before sun
exposure • reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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,

egularly 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 Adipic Acid/Diglycol Crosspolymer, Beeswax,
BHT, C12-15 Alkyl Benzoate, Caprylyl Glycol,
Fragrance, Neopentyl Glycol Diethylhexanoate,
Neopentyl Glycol Diisostearate, Octyldodecyl
Neopentanoate, Ozokerite, Paraffin, Petrolatum,
Polyester-8, Polyethylene, Silica.

QUESTIONS?

OTC - QUESTIONS SECTION

1-888-423-0139

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800425873GTIN-13: 0036800425873
EAN-13: 0036800425873
GTIN-12: 036800425873
UPC-A: 036800425873
GTIN storage (14 digits): 00036800425873		front.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-736-012020-01-31C16284748780-19d75b9d1-12d8-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-736-01Ultimate Sheer SPF 7043 g in 1 PACKAGESTICK431

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-736ULTIMATE SHEER SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% OXYBENZONE 3%) STICK [TOP CARE]1Legacy NDC, 1 package rows20180719_775ac769-d1ab-4e0b-88a4-b64a2d805b11.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-73636800-736-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB
YELLOW WAX2ZA36H0S2VIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
Caprylyl Glycol00YIU5438UIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
Neopentyl Glycol Diisostearate4M6OQ34JWWIACT
Octyldodecyl NeopentanoateX8725R883TIACT
CERESINQ1LS2UJO3AIACT
ParaffinI9O0E3H2ZEIACT
Petrolatum4T6H12BN9UIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML · Source PDF

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
aa961b9c-62a6-412b-b49f-0b77151b68f5775ac769-d1ab-4e0b-88a4-b64a2d805b112018-07-19WarningsExact identifier
spl id: aa961b9c-62a6-412b-b49f-0b77151b68f5
spl set id: 775ac769-d1ab-4e0b-88a4-b64a2d805b11

Reported adverse events (FAERS/openFDA)#

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