SunX SPF 30/BugX Wallmount

SunX SPF 30/BugX Wallmount

Drug Labeling and Warnings

Drug Details

k">

SUNX SPF 30/BUGX WALLMOUNT- sunx spf 30/bugx wallmount 
CoreTex Products

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

SunX SPF 30/BugX Wallmount

Active ingredients

Avobenzone 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

helps prevent sunburn

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 the eyes
  • rinse with water to remove

Stop use and ask a doctor

  • if rash occurs

Keep out of the reach of children

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

Directions

  • apply liberally 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 this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and after sun protection measures including:
  • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months of age: Ask a doctor

Other information

  • protect this product from excessive heat or direct sun

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita extract, dimethicone, dimethyl capramide, ethylparaben, fragrance, glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale leaf extract, tetrasodium EDTA, triethanolamine, tocopherol, tocopherol acetate, water

Questions?

Call: 1-877-684-5774

SunX/BugX Kit Contents

50 count- SunX SPF 30, BugX 30

Principal Display Panel

suns/bugx wall mount

SunX SPF 30 label

SunX SPF 30

SUNX SPF 30/BUGX WALLMOUNT 
sunx spf 30/bugx wallmount kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65753-500
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65753-500-241 in 1 KIT; Type 0: Not a Combination Product11/22/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 125 POUCH 175 mL
Part 1 of 1
CORETEX SUN X SPF 30 THIN 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone liquid
Product Information
Item Code (Source)NDC: 65753-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
CHAMOMILE (UNII: FGL3685T2X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
TROLAMINE (UNII: 9O3K93S3TK)  
ETHYLPARABEN (UNII: 14255EXE39)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
PEG-100 STEARATE (UNII: YD01N1999R)  
COMFREY LEAF (UNII: DG4F8T839X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65753-101-107 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 finalpart35211/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/22/2019
Labeler - CoreTex Products (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products061944620label(65753-101, 65753-500)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories069926483manufacture(65753-101)

Revised: 11/2019
 
CoreTex Products


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.