OTC - ACTIVE INGREDIENT SECTION
Octocrylene 4.0%
Avobenzone 3.0%
Ensulizole 2.5%
SUSANNE KAUFMANN SUNCARE BODY 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 BODY BROAD SPECTRUM PROTECTION SUNSCREEN SPF 25 UVB UVA
Active ingredientOCTOCRYLENE, AVOBENZONE, ENSULIZOLE
Label structure13 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Sunscreen
INDICATIONS & USAGE SECTION
Helps prevent sunburn
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
DOSAGE & ADMINISTRATION SECTION
- Apply generously and evenly 15 minutes before sun exposure
- 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
OTC - ASK DOCTOR SECTION
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
water (aqua), caprylyl-caprylate/caprate, coco-caprylate, pentylene glycol, glycerin, cetearyl olivate, sorbitan olivate, polysilicone-15, sodium hydroxide, pvp/eicosene copolymer, sodium stearoyl glutamate, ectoin, cetyl alcohol, saccharide isomerate (pentavitin), octyldodecanol, cardiospermum halicacabum extract, echium plantagineum seed oil, helianthus annuus (sunflower) oil unsaponifiables, simmondsia chinensis (jojoba) seed oil, squalane, solanum lycopersicum (tomato) fruit extract, brassica oleracea italica (broccoli) seed oil, xanthan gum, tocopheryl acetate, parfum (fragrance), citric acid, sodium phytate.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69937-001-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2846-111a-e063-dadaa90a10e2 | 196c8972-b0a0-6ec6-e054-00144ff88e88 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69937-001-01 | SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREENSPF 25 UVB UVA | 100 mL in 1 BOTTLE, PUMP | LOTION | 100 | 6 | |
| 69937-001-01 | SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREENSPF 25 UVB UVA | 1 in 1 CARTON | LOTION | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69937-001 | SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN SPF 25 UVB UVA (AVOBENZONE, ENSULIZOLE, OCTOCRYLENE) LOTION [SUSANNE KAUFMANN KOSMETIK GMBH] | 6 | Legacy NDC, 2 package rows | 20170716_196c8972-b0a0-6ec6-e054-00144ff88e88.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| ENSULIZOLE | ACTIVE INGREDIENT | 9YQ9DI1W42 | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| ENSULIZOLE | ACTIVE MOIETY | 9YQ9DI1W42 | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| BROCCOLI SEED OIL | INACTIVE INGREDIENT | SY01LVD4G4 | 1 | |
| CAPRYLYL CAPRYLATE/CAPRATE | INACTIVE INGREDIENT | 22MCG4RSMR | 1 | |
| CARDIOSPERMUM HALICACABUM WHOLE | INACTIVE INGREDIENT | 185RQ97K0V | 1 | |
| CETEARYL OLIVATE | INACTIVE INGREDIENT | 58B69Q84JO | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| COCO-CAPRYLATE | INACTIVE INGREDIENT | 4828G836N6 | 1 | |
| ECHIUM PLANTAGINEUM SEED OIL | INACTIVE INGREDIENT | PIB7XBU8XW | 1 | |
| ECTOINE | INACTIVE INGREDIENT | 7GXZ3858RY | 1 | |
| EICOSYL POVIDONE | INACTIVE INGREDIENT | XQQ9MKE2BJ | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 1 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | 1 | |
| PENTYLENE GLYCOL | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| PHYTATE SODIUM | INACTIVE INGREDIENT | 88496G1ERL | 1 | |
| POLYSILICONE-15 | INACTIVE INGREDIENT | F8DRP5BB29 | 1 | |
| SACCHARIDE ISOMERATE | INACTIVE INGREDIENT | W8K377W98I | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| SODIUM STEAROYL GLUTAMATE | INACTIVE INGREDIENT | 65A9F4P024 | 1 | |
| SORBITAN OLIVATE | INACTIVE INGREDIENT | MDL271E3GR | 1 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 1 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 1 | |
| TOMATO | INACTIVE INGREDIENT | Z4KHF2C175 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN SPF 25 UVB UVA
- AVOBENZONE, ENSULIZOLE, OCTOCRYLENE
- SODIUM HYDROXIDE
- BROCCOLI SEED OIL
- CITRIC ACID MONOHYDRATE
- CETEARYL OLIVATE
- SORBITAN OLIVATE
- POLYSILICONE-15
- EICOSYL POVIDONE
- SODIUM STEAROYL GLUTAMATE
- ECTOINE
- CETYL ALCOHOL
- SACCHARIDE ISOMERATE
- OCTYLDODECANOL
- CARDIOSPERMUM HALICACABUM WHOLE
- ECHIUM PLANTAGINEUM SEED OIL
- SUNFLOWER OIL
- JOJOBA OIL
- SQUALANE
- TOMATO
- XANTHAN GUM
- .ALPHA.-TOCOPHEROL ACETATE
- PHYTATE SODIUM
- OCTOCRYLENE
- AVOBENZONE
- ENSULIZOLE
- WATER
- CAPRYLYL CAPRYLATE/CAPRATE
- COCO-CAPRYLATE
- PENTYLENE GLYCOL
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69937-001 | 69937-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | LOTION / TOPICAL | 714 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPERITONEAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, COATED / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-ARTERIAL | 176 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVITREAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER / RESPIRATORY (INHALATION) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVENOUS | 78 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IONTOPHORESIS | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAPLEURAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / VAGINAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRACAUDAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / RETROBULBAR | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SUBCUTANEOUS | 28 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVESICAL | ADJ PH | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | FILM, EXTENDED RELEASE / TRANSDERMAL | 253.4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | ENEMA / RECTAL | 0.44 %v/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RECTAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ORAL | 9 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | OINTMENT / TOPICAL | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / RECTAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRALESIONAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 27 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2f19a887-5b09-44ca-9588-3a7d138b468b | 196c8972-b0a0-6ec6-e054-00144ff88e88 | 2017-07-16 | Warnings | 2f19a887-5b09-44ca-9588-3a7d138b468b 196c8972-b0a0-6ec6-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.