Label: SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN SPF 25 UVB UVA- avobenzone, ensulizole, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69937-001-01 - Packager: Susanne Kaufmann Kosmetik GmbH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 16, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
- 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
- ASK DOCTOR
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN SPF 25 UVB UVA
avobenzone, ensulizole, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69937-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 mg in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 100 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 2.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) BROCCOLI SEED OIL (UNII: SY01LVD4G4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) POLYSILICONE-15 (UNII: F8DRP5BB29) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ECTOINE (UNII: 7GXZ3858RY) CETYL ALCOHOL (UNII: 936JST6JCN) SACCHARIDE ISOMERATE (UNII: W8K377W98I) OCTYLDODECANOL (UNII: 461N1O614Y) CARDIOSPERMUM HALICACABUM WHOLE (UNII: 185RQ97K0V) ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) SQUALANE (UNII: GW89575KF9) TOMATO (UNII: Z4KHF2C175) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHYTATE SODIUM (UNII: 88496G1ERL) WATER (UNII: 059QF0KO0R) CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR) COCO-CAPRYLATE (UNII: 4828G836N6) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69937-001-01 1 in 1 CARTON 07/27/2015 1 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/27/2015 Labeler - Susanne Kaufmann Kosmetik GmbH (300087547) Registrant - Susanne Kaufmann Kosmetik GmbH (300087547) Establishment Name Address ID/FEI Business Operations Island Kinetics, Inc. d.b.a. CoValence Laboratories 959735002 manufacture(69937-001)
