Sun X SPF 30 Thin

Sun X SPF 30 Thin

Drug Labeling and Warnings

Drug Details

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

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

Sunx30 thin spray

CORETEX SUN X SPF 30 THIN 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65753-101
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65753-101-1159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/22/2019
2NDC: 65753-101-12118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/22/2019
3NDC: 65753-101-2716 in 1 BOX11/22/2018
37 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC: 65753-101-2225 in 1 CONTAINER11/22/2019
47 mL in 1 PACKET; Type 0: Not a Combination Product
5NDC: 65753-101-2350 in 1 CONTAINER11/22/2019
57 mL in 1 PACKET; Type 0: Not a Combination Product
6NDC: 65753-101-2450 in 1 CARTON11/22/2019
67 mL in 1 PACKET; Type 0: Not a Combination Product
7NDC: 65753-101-25100 in 1 CARTON11/22/2019
77 mL in 1 PACKET; Type 0: Not a Combination Product
8NDC: 65753-101-26300 in 1 BOX11/22/2019
87 mL in 1 PACKET; Type 0: Not a Combination Product
9NDC: 65753-101-107 mL in 1 POUCH; Type 0: Not a Combination Product11/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/22/2018
Labeler - CoreTex Products (061944620)
Establishment
NameAddressID/FEIBusiness Operations
CoreTex Products061944620label(65753-101)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories069926483manufacture(65753-101)

Revised: 11/2019
 
CoreTex Products


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