FDA.reportPublic FDA data

KiinSun Sunscreen Broad Spectrum SPF50

Manufacturer
Grupo Pogami, S.A. de C.V.
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:12

Label at a glance#

ProductKiinSun Sunscreen Broad Spectrum SPF50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see  Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

for sunscreen use apply generously 15 minutes before sun exposure children under 6 months of age: Ask a doctor reapply: after 40 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, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or highe...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 6.5%

Zinc oxide 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see  Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 if

OTC - STOP USE SECTION

  • 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

  • for sunscreen use
  • apply generously 15 minutes before sun exposure
  • children under 6 months of age: Ask a doctor
  • reapply:
  • after 40 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, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses.

Other information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzoic Acid, Cetyl Alcohol, Chlorophenesin, Deionized Water, Glyceryl Caprylate/Caprate, Glyceryl Stearate, Glycerine, Sorbic Acid Phenoxyethanol, VP/

Questions?

OTC - QUESTIONS SECTION

Toll-free 1-844-KIINSUN

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72431-001-012021-07-23C16284748780-1c7ccaba7-2631-fd44-e053-dadaa90aa01bKiinSun Sunscreen Broad Spectrum SPF50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72431-001-01KiinSun Sunscreen Broad Spectrum SPF50165 g in 1 TUBECREAM1651

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72431-001KIINSUN SUNSCREEN BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [GRUPO POGAMI, S.A. DE C.V.]1Legacy NDC, 1 package rows20200605_c1b744b3-7095-4516-acfa-cc6e3f1c1e68.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72431-00172431-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
CETYL ALCOHOL936JST6JCNIACT
CHLORPHENESINI670DAL4SZIACT
WATER059QF0KO0RIACT
GLYCERYL CAPRYLATE/CAPRATEG7515SW10NIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
SORBIC ACIDX045WJ989BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
a734180e-530a-09fa-e053-2a95a90afd20c1b744b3-7095-4516-acfa-cc6e3f1c1e682020-06-03WarningsExact identifier
spl id: a734180e-530a-09fa-e053-2a95a90afd20
spl set id: c1b744b3-7095-4516-acfa-cc6e3f1c1e68

Reported adverse events (FAERS/openFDA)#

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