Sun X50

Sun X50

Drug Labeling and Warnings

Drug Details

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CORETEX SUN X 50- avobenzone, homosalate, octisalate, octocrylene lotion 
CoreTex Products

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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Sun X50

Active ingredients

Avobenzone

Homosalate

Octisalate

Octocrylene

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other 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 generously and evenly 15 minutes before sun exposure

Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 am to 2 pm
  • wear long-sleeved shirt, pants, hat and sunglasses

reapply

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours

Children under 6 months of age: Ask a doctor.

Other information

  • protect the product from excessive heat and direct sun

Inactive ingredients

benzoic acid, caprylyl methicone, cetyl PEG/PPG-10-1 dimethicone, dicaprylyl ether, edetate disodium, ethylhexylglycerin,glycereth-2 cocoate, stearyl/octyldodecyl citrate crosspolymer, phenoxyethanol, propylene glycol, sodium chloride, water

Questions?

Call 1-877-684-5774

Principal Display Panel

Sun X50

CORETEX SUN X 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65753-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.4 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE12 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MYRISTYL TRISILOXANE (UNII: J7960S4R1T)  
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorwhite (White Lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65753-600-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
2NDC: 65753-600-3244 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
3NDC: 65753-600-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
4NDC: 65753-600-3360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
5NDC: 65753-600-03118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
6NDC: 65753-600-34118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
7NDC: 65753-600-04177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
8NDC: 65753-600-05237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
9NDC: 65753-600-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
10NDC: 65753-600-08473 mL in 1 BAG; Type 0: Not a Combination Product08/16/2019
11NDC: 65753-600-09946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
12NDC: 65753-600-103785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2019
13NDC: 65753-600-397 mL in 1 POUCH; Type 0: Not a Combination Product08/16/2019
14NDC: 65753-600-22175 in 1 CONTAINER08/16/2019
14NDC: 65753-600-397 mL in 1 POUCH; Type 0: Not a Combination Product
15NDC: 65753-600-23350 in 1 CONTAINER08/16/2019
15NDC: 65753-600-397 mL in 1 POUCH; Type 0: Not a Combination Product
16NDC: 65753-600-24350 in 1 CONTAINER08/16/2019
16NDC: 65753-600-397 mL in 1 POUCH; Type 0: Not a Combination Product
17NDC: 65753-600-25700 in 1 CONTAINER08/16/2019
17NDC: 65753-600-397 mL in 1 POUCH; Type 0: Not a Combination Product
18NDC: 65753-600-262100 in 1 CARTON08/16/2019
18NDC: 65753-600-397 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/16/2019
Labeler - CoreTex Products (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTec Products061944620label(65753-600)
Establishment
NameAddressID/FEIBusiness Operations
Health Specialty794053863manufacture(65753-600)

Revised: 8/2019
 
CoreTex Products


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