ELROEL Pang Pang Sun Cushion Plus

Product NDC: 83154-004
11-digit product format: 831540004
Labeler code: 83154
Product ID: 83154-004_3f1d6e22-92ba-f57f-e063-6394a90aa48e
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: 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: ELROEL Pang Pang Sun Cushion Plus
Listing expiration: 2026-12-31

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
5ffaad65-f0b2-416a-b0a3-b92e880641e4	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
83154-004-01	ELROEL Pang Pang Sun Cushion Plus	15 g in 1 CONTAINER	CREAM	15	6
83154-004-02	ELROEL Pang Pang Sun Cushion Plus	1 in 1 CARTON	CREAM	1	6
83154-004-03	ELROEL Pang Pang Sun Cushion Plus	8 g in 1 CONTAINER	CREAM	8	6
83154-004-04	ELROEL Pang Pang Sun Cushion Plus	1 in 1 CARTON	CREAM	1	6
83154-004-05	ELROEL Pang Pang Sun Cushion Plus	25 g in 1 CONTAINER	CREAM	25	6
83154-004-06	ELROEL Pang Pang Sun Cushion Plus	1 in 1 CARTON	CREAM	1	6
83154-004-07	ELROEL Pang Pang Sun Cushion Plus	15 g in 1 CONTAINER	CREAM	15	6
83154-004-08	ELROEL Pang Pang Sun Cushion Plus	1 in 1 POUCH	CREAM	1	6
83154-004-09	ELROEL Pang Pang Sun Cushion Plus	25 g in 1 CONTAINER	CREAM	25	6
83154-004-10	ELROEL Pang Pang Sun Cushion Plus	1 in 1 POUCH	CREAM	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83154-004	ELROEL PANG PANG SUN CUSHION PLUS (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [MONOGLOT HOLDINGS INC.]	5	Current NDC, 10 package rows	20250326_5ffaad65-f0b2-416a-b0a3-b92e880641e4.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 344 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Calico	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	96437795-906f-4e11-ac69-c0c2ae264aae	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cashew	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	b5527aba-5856-44cd-a1d5-f2d7cefb45ea	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	9b641ccb-3046-4b21-8164-b80813090cb4	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	2500fe73-00e2-47ba-9e2b-1c268ed4a9e6	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Bamboo	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	4df1b021-5028-456e-87f2-a96ea6c26c7b	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cedar	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	830a485c-53d4-4fa9-b0cd-0fd2a9bd234b	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8a9fe755-32a2-49b0-8c78-f84bd2ba148f	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c5f3f1bc-adca-495f-b1bc-51c91d42a480	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Uber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	64db3a1f-d6c7-4766-a52c-a4b0c39e2633	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Walnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	582a8244-dab8-4861-9115-2e895a586fb9	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Bronze	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	377405a6-b6c6-4afb-9270-73d933029054	2021-07-13	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Ivory	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	9f7c8d53-6549-4bac-bbae-a2b73fdf6b05	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	5a22b123-9077-4b8a-ac4c-1bdd475c6ac3	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Calico	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	4647828c-661d-4ebe-b27e-13d8b89647b8	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	c82f36da-16ce-45f4-9786-2026a359060a	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Wheat	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	3d86dca5-9e33-4284-a4c1-f5eed64b0620	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Willow	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	0489a046-2173-4137-abff-c6a7cdb5e8fd	2021-07-12	Warnings	Exact identifier application number: M020
H.E.B. Solutions Sunscreen	SPORT SPF 70 LOTION	H.E.B	00cade74-9a8f-4af9-a809-ebf0ff2bbc3c	2021-07-09	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	KIDS SPF 70 LOTION	H.E.B	9f08c40e-b5c6-4ca4-8c24-0a0f98787217	2021-07-09	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	SPORT SPF 50 LOTION	H.E.B	6e45677e-1066-498e-b423-109a94a152aa	2021-07-09	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
83154-004-01	83154000401	15 g in 1 CONTAINER	15 g				Historical
83154-004-02	83154000402	1 CONTAINER in 1 CARTON (83154-004-02) / 15 g in 1 CONTAINER (83154-004-01)	1 container	2024-02-03	No	No	Current
83154-004-03	83154000403	8 g in 1 CONTAINER	8 g				Historical
83154-004-04	83154000404	1 CONTAINER in 1 CARTON (83154-004-04) / 8 g in 1 CONTAINER (83154-004-03)	1 container	2025-01-20	No	No	Current
83154-004-05	83154000405	25 g in 1 CONTAINER	25 g				Historical
83154-004-06	83154000406	1 CONTAINER in 1 CARTON (83154-004-06) / 25 g in 1 CONTAINER (83154-004-05)	1 container	2025-01-20	No	No	Current
83154-004-07	83154000407	15 g in 1 CONTAINER	15 g				Historical
83154-004-08	83154000408	1 CONTAINER in 1 POUCH (83154-004-08) / 15 g in 1 CONTAINER (83154-004-07)	1 container	2025-09-18	No	No	Current
83154-004-09	83154000409	25 g in 1 CONTAINER	25 g				Historical
83154-004-10	83154000410	1 CONTAINER in 1 POUCH (83154-004-10) / 25 g in 1 CONTAINER (83154-004-09)	1 container	2025-09-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
83154-004_ELROEL Pang Pang Sun Cushion Plus	MONOGLOT HOLDINGS Inc. \| Cit Co., Ltd.	2025-09-18	HUMAN OTC DRUG LABEL	6