FDA.reportPublic FDA data

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
IngredientStrength
TITANIUM DIOXIDE1.52 g/100g
ZINC OXIDE9.7 g/100g
OCTINOXATE7 g/100g
OCTISALATE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ffaad65-f0b2-416a-b0a3-b92e880641e4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83154-004-01ELROEL Pang Pang Sun Cushion Plus15 g in 1 CONTAINERCREAM156
83154-004-02ELROEL Pang Pang Sun Cushion Plus1 in 1 CARTONCREAM16
83154-004-03ELROEL Pang Pang Sun Cushion Plus8 g in 1 CONTAINERCREAM86
83154-004-04ELROEL Pang Pang Sun Cushion Plus1 in 1 CARTONCREAM16
83154-004-05ELROEL Pang Pang Sun Cushion Plus25 g in 1 CONTAINERCREAM256
83154-004-06ELROEL Pang Pang Sun Cushion Plus1 in 1 CARTONCREAM16
83154-004-07ELROEL Pang Pang Sun Cushion Plus15 g in 1 CONTAINERCREAM156
83154-004-08ELROEL Pang Pang Sun Cushion Plus1 in 1 POUCHCREAM16
83154-004-09ELROEL Pang Pang Sun Cushion Plus25 g in 1 CONTAINERCREAM256
83154-004-10ELROEL Pang Pang Sun Cushion Plus1 in 1 POUCHCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83154-004ELROEL PANG PANG SUN CUSHION PLUS (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [MONOGLOT HOLDINGS INC.]5Current NDC, 10 package rows20250326_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 22 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unseen Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESupergoop LLC21b3491f-7b02-9bc5-e063-6294a90a0dc32026-06-04WarningsExact identifier
application number: M020
Mineral Glowscreen Soft-Radiance Drops Golden HourZINC OXIDESupergoop LLC1f1be2a7-af96-d73d-e063-6394a90acc1a2026-06-04WarningsExact identifier
application number: M020
Play Antioxidant Body Mist WIth Vitamin C Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC975402e6-8c74-b18e-e053-2995a90a467e2026-06-04WarningsExact identifier
application number: M020
Derma E Sun Drops SPF 30ZINC OXIDEderma e76c29f24-e0d9-4235-b278-96e609bc58db2026-06-04WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
application number: M020
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
application number: M020
BLDG Active Skin Repair Sun Stick Performance SunscreenZINC OXIDEInnovacyn, Inc.a751fc1d-5ee4-4ecc-8ade-2568d91890c42026-06-02WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCAREHOMOSALATE OCTOCRYLENE ETHYLHEXYL SALICYLATEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5347c9a1-2239-b617-e063-6294a90ac6012026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Hydro Booster Moisture SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEOlive International Co., Ltd.4ea2292a-571c-475c-a64c-cbdd1f51f2422026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Daily Invisible Blurring SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOlive International Inc.42325963-0917-43c4-8fe0-130336c7fa812026-06-02WarningsExact identifier
application number: M020
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
application number: M020
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
application number: M020
4ocean REEF SAFE SUNSCREEN SPF 40ZINC OXIDEStream2Sea, LLC52d3d97c-a846-4721-acbe-52a525cb20112026-06-01WarningsExact identifier
application number: M020
APRILSKIN MUGWORT CALMING SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAPR US INC50a7b64a-8b26-97ac-e063-6294a90ad77a2026-06-01WarningsExact identifier
application number: M020
Ultra Violette Future Screen Broad Spectrum SPF 50ZINC OXIDEGrace and Fire USA Inc.252fdc91-bbe2-58ec-e063-6294a90a50672026-06-01WarningsExact identifier
application number: M020
Ultra Violette Vibrant Screen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.2633a289-b3b2-b614-e063-6294a90ad2142026-06-01WarningsExact identifier
application number: M020
Ultra Violette Sequin Supreme SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEGrace and Fire USA Inc.41027faa-7d61-4970-e063-6294a90a7df42026-06-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83154-004-018315400040115 g in 1 CONTAINER15 gHistorical
83154-004-02831540004021 CONTAINER in 1 CARTON (83154-004-02) / 15 g in 1 CONTAINER (83154-004-01) 1 container2024-02-03NoNoCurrent
83154-004-03831540004038 g in 1 CONTAINER8 gHistorical
83154-004-04831540004041 CONTAINER in 1 CARTON (83154-004-04) / 8 g in 1 CONTAINER (83154-004-03) 1 container2025-01-20NoNoCurrent
83154-004-058315400040525 g in 1 CONTAINER25 gHistorical
83154-004-06831540004061 CONTAINER in 1 CARTON (83154-004-06) / 25 g in 1 CONTAINER (83154-004-05) 1 container2025-01-20NoNoCurrent
83154-004-078315400040715 g in 1 CONTAINER15 gHistorical
83154-004-08831540004081 CONTAINER in 1 POUCH (83154-004-08) / 15 g in 1 CONTAINER (83154-004-07) 1 container2025-09-18NoNoCurrent
83154-004-098315400040925 g in 1 CONTAINER25 gHistorical
83154-004-10831540004101 CONTAINER in 1 POUCH (83154-004-10) / 25 g in 1 CONTAINER (83154-004-09) 1 container2025-09-18NoNoCurrent