FDA.reportPublic FDA data

Sunscreen SPF 30

Manufacturer
Tempo Industries, Inc.
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:33

Label at a glance#

ProductSunscreen SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Non-Water Resistant Product Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measuress including: Sun Protection Measures. Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating  Reapply at least every 2 hours Childre...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

WARNINGS:

WARNINGS SECTION

Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn skin cancer or early skin aging. This product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT

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

Directions

DOSAGE & ADMINISTRATION SECTION

Non-Water Resistant Product

Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measuress including: Sun Protection Measures.

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating 
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun

Package Labeling:53ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

53 ml53 ml

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ml30 ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80524-002-302023-12-15C16284748780-1d6a99b39-94ae-a426-e053-dadaa90af4c2Sunscreen SPF 30
80524-002-532023-12-15C16284748780-1d6a99b39-94ae-a426-e053-dadaa90af4c2Sunscreen SPF 30
80524-002-302022-01-28C16284748780-1d6a99b39-94ae-a426-e053-dadaa90af4c2Sunscreen SPF 30
80524-002-532022-01-28C16284748780-1d6a99b39-94ae-a426-e053-dadaa90af4c2Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80524-002-30Sunscreen SPF 3030 mL in 1 BOTTLELOTION303
80524-002-53Sunscreen SPF 3053 mL in 1 BOTTLELOTION533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80524-002SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [TEMPO INDUSTRIES, INC.]3Current NDC, Legacy NDC, 2 package rows20250110_af9aa56d-2f8a-55b9-e053-2a95a90a3258.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
80524-00280524-002-53, 80524-002-30

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
LEVOMENOL24WE03BX2TIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

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
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETempo Industries, Inc.af9aa56d-2f8a-55b9-e053-2a95a90a32582025-01-08WarningsExact identifier
ndc (package): 80524-002-30
ndc (package): 80524-002-53
ndc (product): 80524-002
ndc11 (package): 80524000230
ndc11 (package): 80524000253
spl id: 2b321485-0ffa-4d50-e063-6394a90a9c18
spl set id: af9aa56d-2f8a-55b9-e053-2a95a90a3258

Reported adverse events (FAERS/openFDA)#

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