Cortex Sun X Multi-Pack SPF 30 Thick

Cortex Sun X Multi-Pack SPF 30 Thick

Drug Labeling and Warnings

Drug Details

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SUN X MULTI-PACK SPF 30 THICK- avobenzone, homosalate, octinoxate, octisalate, oxybenzone 
CoreTex Products Inc

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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Cortex Sun X Multi-Pack SPF 30 Thick

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 aska 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 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

Kit Contents

1 Towelette

PRINCIPAL DISPLAY PANEL

SunX Multipack

SUN X MULTI-PACK SPF 30 THICK 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65753-102
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65753-102-2225 in 1 CONTAINER01/01/2017
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC: 65753-102-2325 in 1 CONTAINER01/01/2017
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC: 65753-102-2450 in 1 CONTAINER01/01/2017
31 in 1 POUCH; Type 0: Not a Combination Product
4NDC: 65753-102-31150 in 1 BOX01/01/2017
41 in 1 POUCH; Type 0: Not a Combination Product
5NDC: 65753-102-26300 in 1 BOX01/01/2017
51 in 1 POUCH; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 7 g
Part 1 of 1
SUN X MULTI-PACK SPF 30 THICK 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COMFREY LEAF (UNII: DG4F8T839X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
CHAMOMILE (UNII: FGL3685T2X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart352
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2017
Labeler - CoreTex Products Inc (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products Inc061944620label(65753-102)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories069926483manufacture(65753-102)
Establishment
NameAddressID/FEIBusiness Operations
LICO Industries, LLC.098009041repack(65753-102)

Revised: 6/2019
 
CoreTex Products Inc


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