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 343 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	97e7ece8-a705-4988-ba52-6d3f11573521	2021-12-01	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	6a44f926-11b4-4bc4-8d5d-721a89c4f0cc	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	b58af664-b0fd-4585-8417-7c20954d7aff	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	7bbd1334-fae8-4274-b927-a099af764345	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	970571f9-3d6b-46ae-a668-745de1911fa2	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	542e1b2e-f63c-466b-b5ac-6c147a0e9dec	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	21b65c12-6f67-4053-9508-6b2709cc1fb8	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8ea4c470-ebd5-448e-b72a-ccd1113de0ab	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	fd9689a4-21d1-49f0-bf59-b8e1da72cd16	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Dune	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c23b6a87-8cf9-4be3-8306-2285e7e926c1	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Porcelain	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	a93cb6c6-d7c2-43cc-a2e8-961f896a977e	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	32d99955-1593-426b-958e-5dcf689192a3	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	762deb57-754b-46a9-9907-de05e11da178	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Amber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3b5366e4-180a-4b98-9524-63601ae9d270	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e	2021-11-04	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Calico	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3e67abb5-84a4-4a78-9ea3-9fd57cbeb482	2021-11-04	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	477d79c1-f169-4d0e-a95d-f5e832855f0d	2021-11-04	Warnings	Exact identifier application number: M020
Anhydrous SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	1510cae2-9c8f-45ba-b088-67747af3d30c	2021-07-15	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3f0480e4-b2c3-962c-e063-6294a90a4f23	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	aa708db4-ad90-49b7-a250-5698e4c7d3d6	2021-07-13	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