REPASKIN FACIAL, BROAD SPECTRUM SPF 50- octocrylene, titanium dioxide cream 
Sesvalia USA LLC

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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REPASKIN FACIAL, BROAD SPECTRUM SPF 50

Drug Facts

Active ingredient

Octocrylene 7%

Titanium dioxide 2%

Purpose

Sunscreen

Sunscreen

Uses

  • helps prevent sumbum. 
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

 If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure 
  • reapply:

         after 40 minutes of swimming or sweating. 

         immediately after towel drying 

         at least every 2 hours

  • Sun Protection Measures. 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. 
  • children under 6 months of age: Ask a doctor.

Other information

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, Glycerin, Ethylhexyl Salicylate, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Propanediol, Cyclopentasiloxane, Butyl Methoxydibenzoylmethane, Cetearyl Ethylhexanoate, Lauryl Glucoside, Polyglyceryl-2, Dipolyhydroxystearate, Cetearyl Alcohol, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate,Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspol, Tocopheryl Acetate, Fragance, Cyclohexasiloxane, Disodium EDTA, Ethylhexylglycerin, Propylene Glycol, Xanthan Gum, Hydrolyzed Jojoba Esters, Sodium Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolym, Lecithin, BHT, Alcohol, Sodium PCA, Camellia Oleifera (Geen Tea) Leaf Extract, Silybum Marianum (Carduus Marianus) Extract, Silybum Marianum (Carduus Marianus) Extract,Polysorbate 20, Dipropylene Glycol, Urea, Thermus Thermophillus Ferment, Sodium Cholate, Potassium Sorbate, Hydrolyzed Collagen, Pterostilbene, Sodium Lactate, Sodium Chloride, Methylparaben, Propylparaben, Arabidopsis Thaliana (Arabis Thaliana) Extract, Allantoin, Micrococcus Lysate, Plankton Extract, Hydrochloric Acid,Ergothioneine.

Manufactured by: SESDERMA S.L. Pol. Industrial Rafelbuñol. C/ Massamagrell, 5. 46138 Rafelbuñol.Valencia (Spain) Customer service: 902 100 223. Distributed by: SESVALIA USA LLC. 67 Miracle Mile, Coral Gables, FL 33134 USA. USA Customer service: (1) 800 796 0996. www.sesderma.com Made in SPAIN

REPASKIN FACIAL BROAD SPECTRUM SPF 50, 1.7 fl oz (50 ml) (63181-0011-1)

REPASKIN 50

FACIAL

Sunscreen gel cream

BROAD SPECTRUM SPF 50

1.7 fl oz (50 ml)

sesderma

Manufactured by:

SESDERMA S.L. Pol. Industrial Rafelbuñol. C/ Massamagrell, 5. 46138 Rafelbuñol.Valencia (Spain)

Customer service: 902 100 223.

Distributed by:

SESVALIA USA LLC.

67 Miracle Mile, Coral Gables, FL 33134 USA. USA

Customer service: (1) 800 796 0996.

www.sesderma.com

Made in SPAIN

REPASKINFACIAL50SPF

REPASKIN FACIAL, BROAD SPECTRUM SPF 50 
octocrylene, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63181-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTISALATE (UNII: 4X49Y0596W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PROPANEDIOL (UNII: 5965N8W85T)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
AVOBENZONE (UNII: G63QQF2NOX)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TRIS-BHT MESITYLENE (UNII: 51DM34B894)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
MILK THISTLE (UNII: U946SH95EE)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
UREA (UNII: 8W8T17847W)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
SODIUM CHOLATE (UNII: NU3Y4CCH8Z)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
ALLANTOIN (UNII: 344S277G0Z)  
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
Product Characteristics
Colorwhite (Viscous hazy colorless to off-white liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63181-0011-11 in 1 BOX04/04/201410/31/2015
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/04/201410/31/2015
Labeler - Sesvalia USA LLC (061096093)
Establishment
NameAddressID/FEIBusiness Operations
Sesderma S.L.633606975manufacture(63181-0011)

Revised: 10/2018
Document Id: 79259f32-a685-a7f1-e053-2991aa0aa0b5
Set id: d0b05d7b-cacc-4773-a526-d4b8c8d1c4a4
Version: 2
Effective Time: 20181026
 
Sesvalia USA LLC