FDA.reportPublic FDA data

SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN

Manufacturer
Susanne Kaufmann Kosmetik GmbH | Island Kinetics, Inc. d.b.a. CoValence Laboratories
Effective date
2017-07-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:51:57

Label at a glance#

ProductSUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN SPF 30 UVB UVA
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 3.0%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • Retains SPF after 40 minutes of activity in the water or sweating

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

  • For sunscreen use
  • Apply generously and evenly 15 minutes before sun exposure to all skin exposed to the sun
  • Reapply
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures. Do not remain in the sun for too long, even if you are using a sunscreen product. Even with UV light protection, direct sunlight at noontime is to be avoided. If not enough of the product is used, the sun protection provided is significantly reduced. Avoid excessive sunbathing. Do not expose infants and small children to direct sunlight. 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
  • Ask a doctor before use on children under six month of age

OTHER SAFETY INFORMATION

Do not store above 25°C. protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

coco caprylate, pongamia glabra seed oil, tocopherol, capric caprylic triglyceride, polyhydroxystearic acid, cetearyl alcohol, cetearyl olivate, sorbitan olivate, water, pentylene glycol nat., carrageenan, xanthan gum, sodium polyphosphate, sodium stearoyl glutamate, cardiospermum halicacabum seed extract, glycerin, polygonum aviculare extract, simmondsia chinensis (jojoba) oil, squalene, solanum lycopersicum (tomato) fruit extract, ectoine, lactic acid, parfum (fragrance).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sk-sunscreen-face-MU1704015sk-sunscreen-face-MU1704015

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69937-002-022024-01-30C16284748780-11030e364-ff8b-111a-e063-dadaa90a10e24f05e474-3211-50f5-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69937-002-02SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREENSPF 30 UVB UVA1 in 1 CARTONLOTION16
69937-002-02SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREENSPF 30 UVB UVA50 mL in 1 BOTTLE, PUMPLOTION506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69937-002SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN SPF 30 UVB UVA (ZINC OXIDE) LOTION [SUSANNE KAUFMANN KOSMETIK GMBH]6Legacy NDC, 2 package rows20170716_4f05e474-3211-50f5-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69937-00269937-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
SQUALENE7QWM220FJHIACT
TOMATOZ4KHF2C175IACT
ECTOINE7GXZ3858RYIACT
LACTIC ACID33X04XA5ATIACT
COCO-CAPRYLATE4828G836N6IACT
ZINC OXIDESOI2LOH54ZACTIB
CARRAGEENAN5C69YCD2YJIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL OLIVATE58B69Q84JOIACT
PENTYLENE GLYCOL50C1307PZGIACT
GLYCERINPDC6A3C0OXIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
CARDIOSPERMUM HALICACABUM SEEDY5T803X015IACT
WATER059QF0KO0RIACT
KARUM SEED OIL62160PU6FJIACT
TOCOPHEROLR0ZB2556P8IACT
SORBITAN OLIVATEMDL271E3GRIACT
JOJOBA OIL724GKU717MIACT

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
bf57b01d-2b94-41de-9e2c-d7fadb68000d4f05e474-3211-50f5-e054-00144ff8d46c2017-07-16WarningsExact identifier
spl id: bf57b01d-2b94-41de-9e2c-d7fadb68000d
spl set id: 4f05e474-3211-50f5-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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