COVER CREAM. SUN PROTECTION- octinoxate cream 
Ripar Cosmetici srl

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.

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Cover Cream
Sun Protection Product
Broad Spectrum 18

ACTIVE INGREDIENTS PURPOSE

Oxtinoxate 2% sunscreen

Box

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

WARNINGS

Children under 6 months: ask a doctor

Warnings

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

  • 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

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

Uses

Package Label

CanCan 2

COVER CREAM. SUN PROTECTION 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72399-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CANDELILLA WAX (UNII: WL0328HX19)  
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED PALM OIL (UNII: 257THB963H)  
MICA (UNII: V8A1AW0880)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72399-116-021 in 1 BOX06/27/2018
1NDC:72399-116-014 mL in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/27/2018
Labeler - Ripar Cosmetici srl (338675564)
Registrant - Ripar Cosmetici srl (338675564)
Establishment
NameAddressID/FEIBusiness Operations
338675564338675564manufacture(72399-116)

Revised: 9/2018
Document Id: 768d9c20-9938-1a15-e053-2a91aa0aaefb
Set id: 6fa5f668-52ea-9cc4-e053-2a91aa0a759c
Version: 2
Effective Time: 20180923
 
Ripar Cosmetici srl