Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm

Product NDC: 65753-108
11-digit product format: 657530108
Labeler code: 65753
Product ID: 65753-108_0a949f6f-d5f5-8eb2-e063-6394a90aa6a5
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: CoreTex Products, INC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-01-01
Substance: PETROLATUM; OCTISALATE; OCTINOXATE; AVOBENZONE; HOMOSALATE
Active strength: 40; 5; 7.5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	40 g/100mL
OCTISALATE	5 g/100mL
OCTINOXATE	7.5 g/100mL
AVOBENZONE	3 g/100mL
HOMOSALATE	3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c0355990-b842-47cd-e053-2a95a90a7c82	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	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
65753-108-39	CoreTex Professional Outdoor Skin Protection Wallet	4.44 mL in 1 APPLICATOR	LIPSTICK	65753105 mL	7.5 g in 100mL	3
65753-108-39	CoreTex Professional Outdoor Skin Protection Wallet Refill	4.44 mL in 1 APPLICATOR	LIPSTICK	65753105 mL	40 g in 100mL	1

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
65753-108	CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET KIT [CORETEX PRODUCTS INC]	2	Current NDC, Legacy NDC	20241008_f57bc089-405b-cdcd-e053-2995a90a9d12.zip
65753-108	CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL KIT [CORETEX PRODUCTS INC]	1	Current NDC, Legacy NDC	20231105_095855ef-85f5-dacd-e063-6294a90a597c.zip

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 57 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bath and Body Works SPF At The Beach	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c315bdb-dc33-1737-e063-6294a90a31a4	2026-03-02	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Tahiti Isle	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	38d02c8d-cdc8-b8d6-e063-6294a90ad9e4	2026-03-02	Warnings	Exact identifier application number: M020
Sport	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATE	Old East Main Co.	a460e512-f268-4941-beb6-29df10fdbb3a	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Tanning Sunscreen SPF 15	AVOBENZONE HOMOSALATE OCTISALATE	Old East Main Co.	42258ebe-e3cc-4d70-e063-6294a90a9651	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE	Old East Main Co.	db876d34-1af9-4e0a-9e9a-32a8b00e9405	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE	Old East Main Co.	2ea288fe-815d-4568-9592-55ea428448fa	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	cea1c223-c9d4-42ac-8c5b-c0ca647d57a1	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Old East Main Co.	00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	8f4a6a31-2fae-42fe-924f-10237c59e791	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ef48288b-533f-4924-ba12-fc8cb83643d4	2026-03-02	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	e6976bf4-ad77-4953-858f-4a0ec7f4300c	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	b3d2da09-d9c9-4c27-82fe-a434ece2f099	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ba9331ef-3744-4072-80a2-af95c6f7ee05	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	1a53d8d5-e650-4825-8a3b-7cf42c36e3e5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	086dfda5-9fe7-46b4-9964-4977b86cfdd5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ce9a2139-c5c2-43e2-bd51-1f14ace594d9	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Bask SPF 40 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Surfside Skincare, Inc. dba Bask Suncare	49a30877-e39f-46a3-e063-6394a90a8dd2	2026-03-02	Warnings	Exact identifier application number: M020
Sunscreen SPF30	AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%	Worthy Promotional Products	f6014a97-12d3-4f42-86de-866a206c6c06	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30V	SPF30 BS VANILLA	Epic Laboratories, LLC	02488aad-28be-4ffb-e063-6294a90ad01e	2026-03-02	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043353	benzocaine 6 % Medicated Pad	PSN	f57bc089-405b-cdcd-e053-2995a90a9d12	3
2263170	camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical Gel	PSN	f57bc089-405b-cdcd-e053-2995a90a9d12	3
582753	ethanol 70 % Topical Solution	PSN	f57bc089-405b-cdcd-e053-2995a90a9d12	3
2263166	StingX 6 % Topical Swab	PSN	f57bc089-405b-cdcd-e053-2995a90a9d12	3
2263166	benzocaine 60 MG/ML Medicated Pad [StingX]	SBD	f57bc089-405b-cdcd-e053-2995a90a9d12	3
1043353	benzocaine 60 MG/ML Medicated Pad	SCD	f57bc089-405b-cdcd-e053-2995a90a9d12	3
2263170	camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical Gel	SCD	f57bc089-405b-cdcd-e053-2995a90a9d12	3
582753	ethanol 0.7 ML/ML Topical Solution	SCD	f57bc089-405b-cdcd-e053-2995a90a9d12	3
1043353	benzocaine 6 % Medicated Wipe	SY	f57bc089-405b-cdcd-e053-2995a90a9d12	3
1043353	benzocaine 6 % Topical Swab	SY	f57bc089-405b-cdcd-e053-2995a90a9d12	3
2263170	camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical Gel	SY	f57bc089-405b-cdcd-e053-2995a90a9d12	3
2263170	camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical Gel	SY	f57bc089-405b-cdcd-e053-2995a90a9d12	3
582753	ethanol 70 % Topical Solution	SY	f57bc089-405b-cdcd-e053-2995a90a9d12	3
582753	ethyl alcohol 70 % Topical Solution	SY	f57bc089-405b-cdcd-e053-2995a90a9d12	3
2263166	StingX 60 MG/ML Medicated Pad	SY	f57bc089-405b-cdcd-e053-2995a90a9d12	3
1043353	benzocaine 6 % Medicated Pad	PSN	095855ef-85f5-dacd-e063-6294a90a597c	1
2263170	camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical Gel	PSN	095855ef-85f5-dacd-e063-6294a90a597c	1
1039474	ethanol 62.5 % Topical Solution	PSN	095855ef-85f5-dacd-e063-6294a90a597c	1
2263166	StingX 6 % Topical Swab	PSN	095855ef-85f5-dacd-e063-6294a90a597c	1
2263166	benzocaine 60 MG/ML Medicated Pad [StingX]	SBD	095855ef-85f5-dacd-e063-6294a90a597c	1
1043353	benzocaine 60 MG/ML Medicated Pad	SCD	095855ef-85f5-dacd-e063-6294a90a597c	1
2263170	camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical Gel	SCD	095855ef-85f5-dacd-e063-6294a90a597c	1
1039474	ethanol 0.625 ML/ML Topical Solution	SCD	095855ef-85f5-dacd-e063-6294a90a597c	1
1043353	benzocaine 6 % Medicated Wipe	SY	095855ef-85f5-dacd-e063-6294a90a597c	1
1043353	benzocaine 6 % Topical Swab	SY	095855ef-85f5-dacd-e063-6294a90a597c	1
2263170	camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical Gel	SY	095855ef-85f5-dacd-e063-6294a90a597c	1
2263170	camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical Gel	SY	095855ef-85f5-dacd-e063-6294a90a597c	1
1039474	ethanol 62.5 % Topical Solution	SY	095855ef-85f5-dacd-e063-6294a90a597c	1
2263166	StingX 60 MG/ML Medicated Pad	SY	095855ef-85f5-dacd-e063-6294a90a597c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65753-108-23	65753010823	50 APPLICATOR in 1 CONTAINER (65753-108-23) / 4.44 mL in 1 APPLICATOR	50 applicator	2021-10-08	0000-00-00	No	No	Current
65753-108-36	65753010836	24 APPLICATOR in 1 CONTAINER (65753-108-36) / 4.44 mL in 1 APPLICATOR	24 applicator	2021-10-08	0000-00-00	No	No	Current
65753-108-38	65753010838	72 APPLICATOR in 1 CONTAINER (65753-108-38) / 4.44 mL in 1 APPLICATOR	72 applicator	2021-10-08	0000-00-00	No	No	Current
65753-108-39	65753010839	4.44 mL in 1 APPLICATOR	4.44 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CoreTex Professional Outdoor Skin Protection Wallet and refill 65753-514	CoreTex Products Inc \| Cosmetic Enterprises \| Pure Source \| Raining Rose	2025-10-09	HUMAN OTC DRUG LABEL	3
Sun X 50 Lip Balm 65753-108	CoreTex Products, INC \| OraLabs, Inc.	2023-11-20	HUMAN OTC DRUG LABEL	6
CoreTex Professional Outdoor Skin Protection Wallet Refill 65753-515	CoreTex Products Inc \| Cosmetic Enterprises \| Pure Source \| Raining Rose \| HealthSpecialty	2023-11-04	HUMAN OTC DRUG LABEL	1