NDC | 69937-002-02 |
Set ID | 4f05e474-3211-50f5-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Susanne Kaufmann Kosmetik GmbH |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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 lotionProduct 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)