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

SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN by

Drug Labeling and Warnings

SUSANNE KAUFMANN SUNCARE BODY 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

Octocrylene 4.0%

Avobenzone 3.0%

Ensulizole 2.5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

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

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

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

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

INGREDIENTS AND APPEARANCE

SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN  SPF 25 UVB UVA
avobenzone, ensulizole, octocrylene lotion

Product 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)