ELROEL Pang Pang Sun Cushion S7

Product NDC: 83154-003
11-digit product format: 831540003
Labeler code: 83154
Product ID: 83154-003_4fa148ac-3806-aa2f-e063-6394a90af18e
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Dosage form: CREAM
Route: TOPICAL
Labeler: MONOGLOT HOLDINGS Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-02-03
Substance: TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength: 1.52; 9.7; 7; 3 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: ELROEL Pang Pang Sun Cushion S7
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	1.52 g/100g
ZINC OXIDE	9.7 g/100g
OCTINOXATE	7 g/100g
OCTISALATE	3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	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
256bf56f-aefa-47ce-890c-5a3896c11b92	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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83154-003-01	ELROEL Pang Pang Sun Cushion S7	25 g in 1 CONTAINER	CREAM	25	10
83154-003-02	ELROEL Pang Pang Sun Cushion S7	1 in 1 CARTON	CREAM	1	10
83154-003-03	ELROEL Pang Pang Sun Cushion S7	8 g in 1 CONTAINER	CREAM	8	10
83154-003-04	ELROEL Pang Pang Sun Cushion S7	1 in 1 CARTON	CREAM	1	10
83154-003-05	ELROEL Pang Pang Sun Cushion S7	15 g in 1 CONTAINER	CREAM	15	10
83154-003-06	ELROEL Pang Pang Sun Cushion S7	1 in 1 CARTON	CREAM	1	10
83154-003-07	ELROEL Pang Pang Sun Cushion S7	25 g in 1 CONTAINER	CREAM	25	10
83154-003-08	ELROEL Pang Pang Sun Cushion S7	1 in 1 POUCH	CREAM	1	10
83154-003-09	ELROEL Pang Pang Sun Cushion S7	15 g in 1 CONTAINER	CREAM	15	10
83154-003-10	ELROEL Pang Pang Sun Cushion S7	1 in 1 POUCH	CREAM	1	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83154-003	ELROEL PANG PANG SUN CUSHION S7 (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [MONOGLOT HOLDINGS INC.]	6	Current NDC, 10 package rows	20240428_256bf56f-aefa-47ce-890c-5a3896c11b92.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 301 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	22821e9d-eb3a-4e21-87ae-737b25125534	2024-04-03	Warnings	Exact identifier application number: M020
Meadow and Bark SPF 45 Mineral Shimmer Sunscreen	ZINC OXIDE	Meadow and Bark	14bbd191-ef3b-628e-e063-6294a90a1e66	2024-04-03	Warnings	Exact identifier application number: M020
Meadow and Bark SPF 45 Mineral Sport Sunscreen	ZINC OXIDE	Meadow and Bark	1494c0e1-97f5-411c-e063-6294a90ab2ca	2024-04-03	Warnings	Exact identifier application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F	OCTINOXATE, ZINC OXIDE	BEL STAR S A	ea3a0e07-a277-48c8-e053-2a95a90a172f	2024-04-02	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 BodySpray	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Sol de Janeiro USA, Inc	1520a151-70c4-8699-e063-6294a90adc6b	2024-04-02	Warnings	Exact identifier application number: M020
Meijer SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	075efd92-1632-d8c8-e063-6294a90a8c1a	2024-04-02	Warnings	Exact identifier application number: M020
Good Molecules Sheer Mineral Sunscreen SPF 30	ZINC OXIDE	Good Molecules, LLC	e9596344-a7ab-f582-e053-2a95a90a5525	2024-04-02	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	f5c4186e-f167-40fc-b308-0b4406d3ec55	2024-04-02	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis Holiday	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	95d9a485-7418-437a-8e7d-ebcc09088356	2024-04-02	Warnings	Exact identifier application number: M020
Rejuvenating Priming Moisturizer BS Sunscreen SPF30	ZINC OXIDE	Allure Labs	14cff1a3-89b9-f4da-e063-6394a90a1a41	2024-03-29	Warnings	Exact identifier application number: M020
Lemongrass Spa Products SPF 45 Tinted Mineral Sunscreen	ZINC OXIDE	Lemongrass Spa Products, LLC	14bcbaf9-76a5-f8ba-e063-6294a90a91f6	2024-03-28	Warnings	Exact identifier application number: M020
Rubber Ducky SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carefree Skincare Ventures, LLC	14bd5cf9-423e-53a8-e063-6394a90a29f1	2024-03-28	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	132aab60-da19-7079-e063-6394a90a1d76	2024-03-27	Warnings	Exact identifier application number: M020
NAELI TINT Tinted Mineral Moisturizer SPF 50	ZINC OXIDE	ALLI LLC	25a88843-078b-4589-b8b7-ea439ba6a15b	2024-03-27	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 BodyLotion	ZINC OXIDE	SOL DE JANEIRO USA, INC.	14a85a88-c9a2-94ea-e063-6394a90a4e14	2024-03-27	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 Body Oil	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	SOL DE JANEIRO USA, INC.	14acf152-e72a-debb-e063-6294a90a243d	2024-03-27	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Amber	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0ac71c-e53a-5ff9-e063-6394a90a4807	2024-03-27	Warnings	Exact identifier application number: M020
EltaMD UV Pure SPF47	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc.	9afe900b-4186-4189-a871-ad6f26fc26e4	2024-03-27	Warnings	Exact identifier application number: M020
Eminence Daily Defense Tinted SPF	ZINC OXIDE	Eminence Organic Skin Care	14854bad-317e-154d-e063-6294a90a884f	2024-03-25	Warnings	Exact identifier application number: M020
SPF 50 Mineral Based Facial Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Hutton, Kathleen MD	5cf0d2e3-d496-424c-ac75-70ff5b87e9ca	2024-03-25	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83154-003-01	83154000301	25 g in 1 CONTAINER	25 g				Historical
83154-003-02	83154000302	1 CONTAINER in 1 CARTON (83154-003-02) / 25 g in 1 CONTAINER (83154-003-01)	1 container	2024-02-03	No	No	Current
83154-003-03	83154000303	8 g in 1 CONTAINER	8 g				Historical
83154-003-04	83154000304	1 CONTAINER in 1 CARTON (83154-003-04) / 8 g in 1 CONTAINER (83154-003-03)	1 container	2024-02-03	No	No	Current
83154-003-05	83154000305	15 g in 1 CONTAINER	15 g				Historical
83154-003-06	83154000306	1 CONTAINER in 1 CARTON (83154-003-06) / 15 g in 1 CONTAINER (83154-003-05)	1 container	2026-02-05	No	No	Current
83154-003-07	83154000307	25 g in 1 CONTAINER	25 g				Historical
83154-003-08	83154000308	1 CONTAINER in 1 POUCH (83154-003-08) / 25 g in 1 CONTAINER (83154-003-07)	1 container	2026-04-16	No	No	Current
83154-003-09	83154000309	15 g in 1 CONTAINER	15 g				Historical
83154-003-10	83154000310	1 CONTAINER in 1 POUCH (83154-003-10) / 15 g in 1 CONTAINER (83154-003-09)	1 container	2026-04-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
83154-003_ELROEL Pang Pang Sun Cushion S7	MONOGLOT HOLDINGS Inc. \| Cit Co., Ltd.	2026-04-17	HUMAN OTC DRUG LABEL	10