SUN X SPF 50 BROAD SPECTRUM SUNSCREEN LIP BALM- avobenzone, homosalate, octinoxate, octisalate, petrolatum lipstick

Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm by

Drug Labeling and Warnings

Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm by is a Otc medication manufactured, distributed, or labeled by CoreTex Products, INC, OraLabs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Avobenzone…3.0%

Homosalate…3.0%

Octinoxate......7.5%

Octisalate…...5.0%

Petrolatum....40.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Skin Protectant

Uses

Helps protect against sunburn and chapped lips.

Warnings

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

For external use only.

Stop use and ask a doctor

if rash or irritation develops and lasts.

Keep out of reach of children.

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

Directions:

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Other information:

protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

C12-15 alkyl benzoate, caprylic/capric triglyceride, mineral oil, ozokerite, phenyl trimethicone, tocopherol

Questions?

1.877.684.5774

SunX 50 Lip Balm 65753-108

INGREDIENTS AND APPEARANCE

SUN X SPF 50 BROAD SPECTRUM SUNSCREEN LIP BALM 
avobenzone, homosalate, octinoxate, octisalate, petrolatum lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	40 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
WHITE WAX (UNII: 7G1J5DA97F)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
COCONUT OIL (UNII: Q9L0O73W7L)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-108-36	24 in 1 CONTAINER	10/08/2021
1		4.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 65753-108-23	50 in 1 CONTAINER	10/08/2021
2		4.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 65753-108-38	72 in 1 CONTAINER	10/08/2021
3		4.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2017

Labeler - CoreTex Products, INC (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products, INC		061944620	pack(65753-108)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs, Inc.		801824756	manufacture(65753-108)