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 255 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BabyGanics Sunscreen 30 SPF	ZINC OXIDE, OCTINOXATE, AND OCTISALATE	KAS Direct LLC dba BabyGanics	391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAIN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ac9a5-f609-d804-e063-6394a90abd05	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ad424-16a8-66b1-e063-6394a90a0753	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afef9-758f-74e1-e063-6294a90a8072	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3276-7973-d33f-e063-6294a90a6ce1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TAN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afe24-d496-5745-e063-6394a90aa1b3	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b1f9a-34fd-cb50-e063-6394a90af925	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SAND	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3236-3f3d-c9e8-e063-6394a90a7443	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b416d-ce02-3462-e063-6294a90a38f0	2024-12-19	Warnings	Exact identifier application number: M020
Puttisu	TITANIUM DIOXIDE, ZINC OXIDE	Jellycup, Inc.	a032331a-6724-d2cd-e053-2995a90ac15a	2024-12-19	Warnings	Exact identifier application number: M020
Dr. C. Tuna Resurface Essential Day Cream SPF 30	HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE	Farmasi US LLC	de493e30-d135-9def-e053-2995a90ae49a	2024-12-19	Warnings	Exact identifier application number: M020
toty Ilumina CC Cream 1N	TITANIUM DIOXIDE, ZINC OXIDE	Chipican LLC	e4efe14e-7d46-78c0-e053-2995a90a2364	2024-12-19	Warnings	Exact identifier application number: M020
Aruba Sun SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d8b28ce6-e938-c6e3-e053-2a95a90acc29	2024-12-19	Warnings	Exact identifier application number: M020
DCH Pain Relief Roll-On	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	fda35d37-f36e-efc8-e053-6294a90a2bb8	2024-12-19	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 50 Kids	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d53ff8f5-0b06-1e8b-e053-2a95a90ab924	2024-12-19	Warnings	Exact identifier application number: M020
Fresh Coast SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	043cadde-ba07-7c77-e063-6394a90abee6	2024-12-19	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%	Derma Care Research Labs, LLC	d438be95-0f88-69d7-e053-2995a90a982e	2024-12-19	Warnings	Exact identifier application number: M020
Pavin SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	e945f9df-0aed-469c-e053-2995a90ab6aa	2024-12-19	Warnings	Exact identifier application number: M020
Bee Bald Smooth Plus Daily Moisturizer SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6%	Derma Care Research Labs, LLC	051b68f9-5d6b-3cd7-e063-6394a90aeb35	2024-12-19	Warnings	Exact identifier application number: M020
MKMen Advanced Facial Hydrator Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	484e92db-09a2-4e93-aa7e-d91dbda31555	2024-12-19	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