Active ingredients

Avobenzone 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Purpose

Sunscreen

Uses

helps prevent sunburn
higher SPF gives more sunburn protection.
retains SPF after 80 minutes of activity in the water or sweating
provides high protection against sunburn.

Warnings

For external use only.

Do not use

on damaged or broken skin

When using this product

keep out of the eye. Rinse with water to remove.

Stop use and ask a doctor if

rash or irritation develops and lasts

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

apply liberally 15 minutes before sun exposure

Reapply:
after 80 minutes of swimming or sweating
- after towel drying, swimming, or
- at least every 2 hours

children under 6 months of age: ask a doctor.

Other information

protect this product from excessive heat and direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients:

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita (matricaria) extract, C12-15 alkyl benzoate, dimethicone, dimethyl capramide, ethylparaben, fragrance (parfum), glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale (watercress) extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale (comfrey) leaf extract, tetrasodium EDTA, tocopherol, tocopheryl acetate, triethanolamine, water

Questions and comments?

Call: 1-877-684-5774

Principal Display Panel
101-12

101

101-11

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PEG-100 STEARATE (UNII: YD01N1999R)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
COMFREY LEAF (UNII: DG4F8T839X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)
FRAGRANCE 13576 (UNII: 5EM498GW35)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	11/21/2022
3		7 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC:65753-101-22	25 in 1 CONTAINER	11/22/2019	11/21/2022
4		7 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC:65753-101-23	50 in 1 CONTAINER	11/22/2019	11/21/2022
5		7 mL in 1 PACKET; Type 0: Not a Combination Product
6	NDC:65753-101-24	50 in 1 CARTON	11/22/2019	11/21/2022
6		7 mL in 1 PACKET; Type 0: Not a Combination Product
7	NDC:65753-101-25	100 in 1 CARTON	11/22/2019	11/21/2022
7		7 mL in 1 PACKET; Type 0: Not a Combination Product
8	NDC:65753-101-26	300 in 1 BOX	11/22/2019	11/21/2022
8		7 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/22/2018

Labeler - CoreTex Products Inc (061944620)

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

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

Sun X SPF 30 Thin 65753-101