FDA.reportPublic FDA data

Sunscreen SPF 70

Manufacturer
Top Care | Product Quest Mfg, LLC
Effective date
2018-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:09

Label at a glance#

ProductSunscreen SPF 70
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure12 sections

Indications and uses

Uses • helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least 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, especi...

Label contents#

Full prescribing information#

Active ingredients   

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Uses • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

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

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least 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
  • children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Behenyl Alcohol, Benzyl Alcohol, Butylated PVP, Butylene Glycol, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Chlorphenesin, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glyceryl Stearate, Lauryl Alcohol, Lecithin, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Water.

Other information

OTHER SAFETY 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
36800-716-062020-01-31C16284748780-19d75b9d0-62f8-f424-e053-dadaa90a57ceDaylogic Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-716-06Sunscreen SPF 70237 mL in 1 BOTTLELOTION2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-716SUNSCREEN SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% OXYBENZONE 6%) LOTION [TOP CARE]1Legacy NDC, 1 package rows20180704_a24d01d9-066a-467d-bb7b-1e41c66eecff.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-71636800-716-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
DOCOSANOL9G1OE216XYIACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CETYL ALCOHOL936JST6JCNIACT
CHLORPHENESINI670DAL4SZIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURYL ALCOHOL178A96NLP2IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MYRISTYL ALCOHOLV42034O9PUIACT
PALMITIC ACID2V16EO95H1IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT

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
fd6d6bdf-165a-4e2e-a0f7-f26886453700a24d01d9-066a-467d-bb7b-1e41c66eecff2018-07-03WarningsExact identifier
spl id: fd6d6bdf-165a-4e2e-a0f7-f26886453700
spl set id: a24d01d9-066a-467d-bb7b-1e41c66eecff

Reported adverse events (FAERS/openFDA)#

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