Cover Cream. Sun protection

Manufacturer
Ripar Cosmetici srl | 338675564
Effective date
2018-09-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:44

Label at a glance#

ProductCover Cream. Sun protection
Active ingredientOCTINOXATE
Label structure9 sections

Indications and 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

Dosage and administration

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 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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Oxtinoxate 2% sunscreen

BoxBox

Warnings

WARNINGS SECTION

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

WARNINGS

OTC - ASK DOCTOR SECTION

Children under 6 months: ask a doctor

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Questions or comments?

OTC - QUESTIONS SECTION

1- 800-775-1827. M-F 9:00 am to 5:00 pm EST

www.ripar.us

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Directions

INSTRUCTIONS FOR USE SECTION

  • 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 SECTION

  • 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

INDICATIONS & USAGE SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Uses

OTC - PURPOSE SECTION

  • 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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CanCanCan 2Can 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72399-129-022020-01-31C16284748780-19d75b9d0-0c2e-f424-e053-dadaa90a57ceCover Cream Sun Protection Product Broad Spectrum 18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72399-129-01Cover Cream. Sun protection4 mL in 1 CYLINDERCREAM42
72399-129-02Cover Cream. Sun protection1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72399-129COVER CREAM. SUN PROTECTION (OCTINOXATE) CREAM [RIPAR COSMETICI SRL]2Legacy NDC, 2 package rows20180905_6fa6a261-5146-3151-e053-2991aa0ae4e6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72399-12972399-129-01, 72399-129-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
75168011-560e-0f9f-e053-2a91aa0aae2a6fa6a261-5146-3151-e053-2991aa0ae4e62018-09-04WarningsExact identifier
spl id: 75168011-560e-0f9f-e053-2a91aa0aae2a
spl set id: 6fa6a261-5146-3151-e053-2991aa0ae4e6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.