SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN SPF 25 UVB UVA- avobenzone, ensulizole, octocrylene lotion 
Susanne Kaufmann Kosmetik GmbH

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.

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Octocrylene 4.0%

Avobenzone 3.0%

Ensulizole 2.5%

Sunscreen

Helps prevent sunburn

For external use only

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children

Ask a doctor before use on children under six month of age

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

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

SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN  SPF 25 UVB UVA
avobenzone, ensulizole, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69937-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69937-001-011 in 1 CARTON07/27/2015
1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/27/2015
Labeler - Susanne Kaufmann Kosmetik GmbH (300087547)
Registrant - Susanne Kaufmann Kosmetik GmbH (300087547)
Establishment
NameAddressID/FEIBusiness Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories959735002manufacture(69937-001)

Revised: 7/2017
Document Id: 2f19a887-5b09-44ca-9588-3a7d138b468b
Set id: 196c8972-b0a0-6ec6-e054-00144ff88e88
Version: 6
Effective Time: 20170716
 
Susanne Kaufmann Kosmetik GmbH