Sun X SPF 30 Thick

Sun X SPF 30 Thick

Drug Labeling and Warnings

Drug Details

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CORETEX SUN X SPF 30- avobenzone, homosalate, octinoxate, octisalate, oxybenzone 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 X 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 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

Principal Display Panel

image of pdp image of pdp

CORETEX SUN X SPF 30 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65753-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
CHAMOMILE (UNII: FGL3685T2X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
COMFREY LEAF (UNII: DG4F8T839X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Product Characteristics
Colorwhite (Thick White Lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65753-100-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
2NDC: 65753-100-3244 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
3NDC: 65753-100-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
4NDC: 65753-100-3359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
5NDC: 65753-100-03118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
6NDC: 65753-100-34118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
7NDC: 65753-100-04177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
8NDC: 65753-100-05236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
9NDC: 65753-100-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
10NDC: 65753-100-09946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
11NDC: 65753-100-103785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2013
12NDC: 65753-100-3744 mL in 1 PACKET; Type 0: Not a Combination Product01/25/2013
13NDC: 65753-100-181000 in 1 CARTON01/25/2013
1344 mL in 1 PACKET; Type 0: Not a Combination Product
14NDC: 65753-100-2225 in 1 CONTAINER01/25/2013
14207 mL in 1 PACKET; Type 0: Not a Combination Product
15NDC: 65753-100-2350 in 1 CONTAINER01/25/2013
15207 mL in 1 PACKET; Type 0: Not a Combination Product
16NDC: 65753-100-2450 in 1 CARTON01/25/2013
16207 mL in 1 PACKET; Type 0: Not a Combination Product
17NDC: 65753-100-25100 in 1 CARTON01/25/2013
17207 mL in 1 PACKET; Type 0: Not a Combination Product
18NDC: 65753-100-26300 in 1 BOX01/25/2013
18207 mL in 1 PACKET; Type 0: Not a Combination Product
19NDC: 65753-100-081 in 1 BOX01/25/2013
19500 mL in 1 BAG; Type 0: Not a Combination Product
20NDC: 65753-100-401 in 1 BOX01/01/2017
20NDC: 65753-100-35751 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 finalpart35201/25/2013
Labeler - CoreTex Products (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products061944620label(65753-100)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source080354456manufacture(65753-100)

Revised: 11/2019
 
CoreTex Products


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