SUNX SPF 30/BUGX WALLMOUNT kit

SunX SPF 30/BugX Wallmount by

Drug Labeling and Warnings

SunX SPF 30/BugX Wallmount by is a Otc medication manufactured, distributed, or labeled by CoreTex Products Inc, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Free Kit Contents

25- SunX SPF 30

25- BugX Free

SunX 30/BugX Free Wallmount Principal Display Panel

SunX SPF 30 label

INGREDIENTS AND APPEARANCE

SUNX SPF 30/BUGX WALLMOUNT 
sunx spf 30/bugx wallmount kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-501

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-501-24	1 in 1 KIT; Type 0: Not a Combination Product	11/22/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	25 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-101-10	7 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/22/2019

Labeler - CoreTex Products (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products		061944620	label(65753-101, 65753-501)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		080354456	manufacture(65753-101)