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 260 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AHAVA Protecting Body Broad Spectrum SPF 30	AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	e188c328-3617-4f02-8bc9-47976acf3711	2024-12-17	Warnings	Exact identifier application number: M020
Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer Tint	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	a1cab79d-0151-49ee-86dc-c2739842e62e	2024-12-17	Warnings	Exact identifier application number: M020
SPF 50 plus Sunscreen	TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE	KAS Direct LLC dba BabyGanics	5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b	2024-12-17	Warnings	Exact identifier application number: M020
Even Up Sunscreen SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	f9d375af-3c8b-4462-b729-fdd4be929284	2024-12-17	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d842103-7157-793a-e063-6394a90a6feb	2024-12-16	Warnings	Exact identifier application number: M020
SPF15 natural lip balm 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	295f2a15-19fa-011f-e063-6394a90aea7b	2024-12-16	Warnings	Exact identifier application number: M020
BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15	AVOBENZONE, OCTINOXATE, AND OCTISALATE	Bobbi Brown Professional Cosmetics Inc.	4bfbfac7-6738-4996-a152-95dfbd759154	2024-12-16	Warnings	Exact identifier application number: M020
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Bobbi Brown Professional Cosmetics Inc.	dc6b28ca-b922-460a-8028-fb3f5afdbe9d	2024-12-16	Warnings	Exact identifier application number: M020
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30	OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE	Bobbi Brown Professional Cosmetics Inc.	1f9a4b71-45aa-4156-9fe6-ffa81f808a85	2024-12-16	Warnings	Exact identifier application number: M020
AHAVA Protecting Moisturizing SPF50	AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	7502e06d-754b-4cb8-ba4c-91eee0453932	2024-12-16	Warnings	Exact identifier application number: M020
Natural Finish Pressed Foundation SPF 20 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	c389e183-bfad-4813-af09-fae3aa05e82a	2024-12-16	Warnings	Exact identifier application number: M020
Sunforgettable Total Protection Brush-On Shield SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	c77357f1-7ada-4325-86f7-5ee801610f42	2024-12-16	Warnings	Exact identifier application number: M020
Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30	ZINC OXIDE	Colorescience	5b6f906e-6620-48b0-9c39-0eb1c8dc1c63	2024-12-16	Warnings	Exact identifier application number: M020
Ryshi SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Rite Aid	e313350f-74d9-370b-e053-2995a90aeeaf	2024-12-15	Warnings	Exact identifier application number: M020
Annmarie SPF 20 Sunscreen	ZINC OXIDE 15%	Annmarie Gianni Skin Care LLC	cc722ce1-0ded-19d5-e053-2995a90a7d03	2024-12-15	Warnings	Exact identifier application number: M020
Zinka SPF 30 Clear Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%	Zinka, Inc	c054ac39-d03f-17c1-e053-2a95a90aa5ef	2024-12-15	Warnings	Exact identifier application number: M020
QC SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	CDMA	f82080b1-ef90-a027-e053-6294a90a19f2	2024-12-15	Warnings	Exact identifier application number: M020
QC SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%	CDMA	f80ceb05-0bd4-1355-e053-6294a90afb19	2024-12-15	Warnings	Exact identifier application number: M020
Lip Shine SPF35 Sunscreen	ZINC OXIDE	Colorescience	3a6506c4-1ba9-493a-a4c8-e5f9c60d221b	2024-12-13	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEP	ZINC OXIDE	COSMAX USA, CORPORATION	292165af-545d-db43-e063-6394a90ad183	2024-12-13	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