Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm

Manufacturer: CoreTex Products, INC | OraLabs, Inc.
Effective date: 2023-11-20
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:03:48

Label at a glance#

ProductSun X SPF 50 Broad Spectrum Sunscreen Lip Balm

Active ingredientPETROLATUM, OCTISALATE, OCTINOXATE, AVOBENZONE, HOMOSALATE

Label structure9 sections

Indications and uses

Helps protect against sunburn and chapped lips.

Dosage and administration

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Contacts and useful links#

PhoneLabel contact1.877.684.5774

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone…3.0%

Homosalate…3.0%

Octinoxate......7.5%

Octisalate…...5.0%

Petrolatum....40.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps protect against sunburn and chapped lips.

Warnings

WARNINGS SECTION

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.

WARNINGS SECTION

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

if rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally before sun exposure and as needed.

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

Other information:

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1.877.684.5774

SunX 50 Lip Balm 65753-108

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunx50 lip balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65753-108-23	Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm	4.44 mL in 1 APPLICATOR	LIPSTICK	4.44	6
65753-108-23	Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm	50 in 1 CONTAINER	LIPSTICK	50	6
65753-108-36	Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm	24 in 1 CONTAINER	LIPSTICK	24	6
65753-108-36	Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm	4.44 mL in 1 APPLICATOR	LIPSTICK	4.44	6
65753-108-38	Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm	4.44 mL in 1 APPLICATOR	LIPSTICK	4.44	6
65753-108-38	Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm	72 in 1 CONTAINER	LIPSTICK	72	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65753-108	SUN X SPF 50 BROAD SPECTRUM SUNSCREEN LIP BALM (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUM) LIPSTICK [CORETEX PRODUCTS, INC]	6	Current NDC, Legacy NDC, 6 package rows	20231210_c0355990-b842-47cd-e053-2a95a90a7c82.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm
Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum
PETROLATUM
OCTISALATE
OCTINOXATE
AVOBENZONE
HOMOSALATE
MINERAL OIL
WHITE WAX
ALKYL (C12-15) BENZOATE
COCONUT OIL
PHENYL TRIMETHICONE
TOCOPHEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65753-108	65753-108-36, 65753-108-23, 65753-108-38

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
MINERAL OIL	T5L8T28FGP	IACT
WHITE WAX	7G1J5DA97F	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
COCONUT OIL	Q9L0O73W7L	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
TOCOPHEROL	R0ZB2556P8	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUM	CoreTex Products, INC	c0355990-b842-47cd-e053-2a95a90a7c82	2023-11-20	Warnings	Exact identifier ndc (package): 65753-108-38 ndc (package): 65753-108-23 ndc (package): 65753-108-36 ndc (product): 65753-108 ndc11 (package): 65753010823 ndc11 (package): 65753010838 ndc11 (package): 65753010836 spl id: 0a949f6f-d5f5-8eb2-e063-6394a90aa6a5 spl set id: c0355990-b842-47cd-e053-2a95a90a7c82

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.