SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN SPF 30 UVB UVA- zinc oxide 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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Zinc oxide 3.0%

Sunscreen

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

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

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

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).

sk-sunscreen-face-MU1704015

SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN  SPF 30 UVB UVA
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69937-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SQUALENE (UNII: 7QWM220FJH)  
TOMATO (UNII: Z4KHF2C175)  
ECTOINE (UNII: 7GXZ3858RY)  
LACTIC ACID (UNII: 33X04XA5AT)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
CARDIOSPERMUM HALICACABUM SEED (UNII: Y5T803X015)  
WATER (UNII: 059QF0KO0R)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
JOJOBA OIL (UNII: 724GKU717M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69937-002-021 in 1 CARTON06/01/2017
150 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 finalpart35206/01/2017
Labeler - Susanne Kaufmann Kosmetik GmbH (300087547)
Registrant - Susanne Kaufmann Kosmetik GmbH (300087547)
Establishment
NameAddressID/FEIBusiness Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories959735002manufacture(69937-002)

Revised: 7/2017
Document Id: bf57b01d-2b94-41de-9e2c-d7fadb68000d
Set id: 4f05e474-3211-50f5-e054-00144ff8d46c
Version: 6
Effective Time: 20170716
 
Susanne Kaufmann Kosmetik GmbH