SUN X MULTI-PACK SPF 30 THICK- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Sun X Multi-Pack SPF 30 Thick by

Drug Labeling and Warnings

Sun X Multi-Pack SPF 30 Thick 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 aska doctor if

• rash occurs

Keep out of 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

Kit Contents

1 Towelette

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN X MULTI-PACK SPF 30 THICK 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-102
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLPARABEN (UNII: 14255EXE39)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-100 STEARATE (UNII: YD01N1999R)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
COMFREY LEAF (UNII: DG4F8T839X)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-102-22	25 in 1 CONTAINER	01/01/2017
1		7 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 65753-102-23	25 in 1 CONTAINER	01/01/2017
2		7 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 65753-102-24	50 in 1 CONTAINER	01/01/2017
3		7 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 65753-102-31	150 in 1 BOX	01/01/2017
4		7 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 65753-102-26	300 in 1 BOX	01/01/2017
5		7 g 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	01/01/2017

Labeler - CoreTex Products Inc (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products Inc		061944620	label(65753-102)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		080354456	manufacture(65753-102)