SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN SPF 30 UVB UVA- zinc oxide lotion

SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN by

Drug Labeling and Warnings

SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Susanne Kaufmann Kosmetik GmbH, Island Kinetics, Inc. d.b.a. CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc oxide 3.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

WARNINGS

For external use only

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

• 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

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).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN  SPF 30 UVB UVA
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69937-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69937-002-02	1 in 1 CARTON	06/01/2017
1		50 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 final	part352	06/01/2017

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(69937-002)