Active Ingredients Purpose
Oxtinoxate 2% sunscreen
Box (Box)
Cover Cream. Sun Protection
FDA Label NDC 72399-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ripar Cosmetici Srl for the product Cover Cream. Sun Protection (NDC 72399-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients purpose, warnings, questions or comments?, other information, directions, dosage & administration, uses, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
SUN ALERT: Limiting sun exposures, wearing protective clothing and using sunscreens may reduce the risks of skin aging. skin cancer, and other harmful effects of the sun
For external use only.
Do not use on damaged or broken skin.
When using this product keep our of the eyes. Rinse with water to remove.
SUN PROTECTION MEASURES. Spending times 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 15 or higher and other sun protection measures including: limit time to the sun especially from 10:00 am to 2:00 pm. Weat long sleeve shirts , pants, hats and sunglasses
DIscontinue uses if signs or irritationsor rash appears. If irritation or rash persists, consult with a doctor.
Keep out of reach of children. If swallowed, get medical help or Contact Poison Control Central right away
Children under 6 months ask a doctor
Children under 6 months: ask a doctor
Keep out of reach of children
Questions Or Comments?
1- 800-775-1827. M-F 9:00 am to 5:00 pm EST
www.ripar.us
Other Information
Protect this product from excessive heat and direct sun
Directions
- provides minimun protection against sunburn
- if used as directed with other sun protection measures (see directions), decreases the risks of skin cancer and early skin aging caused by the sun
Dosage & Administration
- apply liberally 15 minutes before sun exposure reapply adter 40 or 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours
- children under 6 months of age, consult with a doctor
Uses
- provides minimun protection against sunburn
- if used as directed with other sun protection measures (see directions), decreases the risks of skin cancer and early skin aging caused by the sun
- provides minimun protection against sunburn
- if used as directed with other sun protection measures (see directions), decreases the risks of skin cancer and early skin aging caused by the sun
Inactive Ingredients
CAPRYLIC/CAPRIC TRIGLYCERIDE, MEDIUM CHAIN TRIGLYCERIDES, BEESWAX YELLOW WAX, CANDELILLA WAX, OCTINOXATE, DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE, MAGNESIUM CARBONATE, SILICON DIOXIDE, HYDROGENATED PALM, MICA, TOCOPHEROL , PHENOXYETHANOL, FERRIC OXIDE YELLOW , FERRIC OXIDE RED, TITANIUM DIOXIDE, FERROSOFERRIC OXIDE
Package Label
Can (Can1small)
Can 2 (Can2small)
* Please review the disclaimer below.
