SUSANNE KAUFMANN Suncare: Package Insert and Label Information

SUSANNE KAUFMANN SUNCARE- 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.

Zinc oxide 3.0%

Sunscreen

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

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.

  • 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

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).

carton
(click image for full-size original)

SUSANNE KAUFMANN SUNCARE
face broad spectrum protection sunscreen lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69937-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SQUALENE
TOMATO
ECTOINE
LACTIC ACID
COCO-CAPRYLATE
CARRAGEENAN
XANTHAN GUM
SODIUM POLYMETAPHOSPHATE
SODIUM STEAROYL GLUTAMATE
MEDIUM-CHAIN TRIGLYCERIDES
POLYHYDROXYSTEARIC ACID (2300 MW)
CETOSTEARYL ALCOHOL
CETEARYL OLIVATE
PENTYLENE GLYCOL
GLYCERIN
POLYGONUM AVICULARE TOP
CARDIOSPERMUM HALICACABUM SEED
WATER
KARUM SEED OIL
TOCOPHEROL
SORBITAN OLIVATE
JOJOBA OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69937-002-02 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 50 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (69937-002-02)
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 Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories 959735002 manufacture (69937-002)

Revised: 07/2017 Susanne Kaufmann Kosmetik GmbH

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.