Active ingredient A list of the active, medicinal ingredients in the drug product.
Zinc oxide 3.0%
Dosage and administration Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
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).
Indications and usage A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Helps prevent sunburn Higher SPF gives more sunburn protection Retains SPF after 40 minutes of activity in the water or sweating
Purpose Information about the drug product’s indications for use.
Spl product data elements Usually a list of ingredients in a drug product.
SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN SPF 30 UVB UVA ZINC OXIDE SQUALENE TOMATO ECTOINE LACTIC ACID COCO-CAPRYLATE ZINC OXIDE ZINC OXIDE 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
Package label principal display panel The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Do not use Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin.
Keep out of reach of children Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away.
Other safety information Information about safe use and handling of the product that may not have been specified in another field.
Do not store above 25°C. protect the product in this container from excessive heat and direct sun
Stop use Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs
When using Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.
Warnings Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
For external use only