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

CoreTex Sun X SPF 30 Thin by

Drug Labeling and Warnings

CoreTex Sun X SPF 30 Thin 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

Principal Display Panel

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 mL
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-101-11	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/22/2019
2	NDC: 65753-101-12	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/22/2019
3	NDC: 65753-101-27	16 in 1 BOX	11/22/2018
3		7 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 65753-101-22	25 in 1 CONTAINER	11/22/2019
4		7 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 65753-101-23	50 in 1 CONTAINER	11/22/2019
5		7 mL in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 65753-101-24	50 in 1 CARTON	11/22/2019
6		7 mL in 1 PACKET; Type 0: Not a Combination Product
7	NDC: 65753-101-25	100 in 1 CARTON	11/22/2019
7		7 mL in 1 PACKET; Type 0: Not a Combination Product
8	NDC: 65753-101-26	300 in 1 BOX	11/22/2019
8		7 mL in 1 PACKET; 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	11/22/2018

Labeler - CoreTex Products (061944620)

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

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