FDA.reportPublic FDA data

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
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
256bf56f-aefa-47ce-890c-5a3896c11b92Available 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
83154-003-01ELROEL Pang Pang Sun Cushion S725 g in 1 CONTAINERCREAM2510
83154-003-02ELROEL Pang Pang Sun Cushion S71 in 1 CARTONCREAM110
83154-003-03ELROEL Pang Pang Sun Cushion S78 g in 1 CONTAINERCREAM810
83154-003-04ELROEL Pang Pang Sun Cushion S71 in 1 CARTONCREAM110
83154-003-05ELROEL Pang Pang Sun Cushion S715 g in 1 CONTAINERCREAM1510
83154-003-06ELROEL Pang Pang Sun Cushion S71 in 1 CARTONCREAM110
83154-003-07ELROEL Pang Pang Sun Cushion S725 g in 1 CONTAINERCREAM2510
83154-003-08ELROEL Pang Pang Sun Cushion S71 in 1 POUCHCREAM110
83154-003-09ELROEL Pang Pang Sun Cushion S715 g in 1 CONTAINERCREAM1510
83154-003-10ELROEL Pang Pang Sun Cushion S71 in 1 POUCHCREAM110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83154-003ELROEL PANG PANG SUN CUSHION S7 (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [MONOGLOT HOLDINGS INC.]6Current NDC, 10 package rows20240428_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 274 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7961ff9f-75db-4977-e053-2a91aa0ae6282024-10-27WarningsExact identifier
application number: M020
Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8a1c9a3c-394e-9122-e053-2995a90acb232024-10-27WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8b889b75-07ac-4276-e053-2a95a90a69c62024-10-27WarningsExact identifier
application number: M020
Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC9751a700-5d51-357b-e053-2a95a90af66c2024-10-27WarningsExact identifier
application number: M020
Banana Boat Sport Ultra Face SPF30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc757b03-7e7d-b362-e053-2a95a90a84462024-10-27WarningsExact identifier
application number: M020
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
application number: M020
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe5f9d56d-a80e-221c-e053-2a95a90aae922024-10-27WarningsExact identifier
application number: M020
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe53509bf-6bb7-2db7-e053-2a95a90aae182024-10-27WarningsExact identifier
application number: M020
Banana Boat Sport Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc79790f-e2bc-5414-e053-2a95a90a9e7a2024-10-27WarningsExact identifier
application number: M020
Hawaiian Tropic Everyday Active SPF15AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc8ca3ed-5411-6278-e053-2995a90a0efc2024-10-27WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC16b4342e-6705-ca09-e063-6294a90a947d2024-10-27WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC17670182-2b2e-ce40-e063-6294a90a29132024-10-27WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC16b3c10c-d98b-c424-e063-6394a90a77342024-10-27WarningsExact identifier
application number: M020
TiZO Mineral Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDfd6d0080-0bef-4e7e-8ca5-b859639efd0c2024-10-25WarningsExact identifier
application number: M020
Alumier MD Post Procedure Kit with HydrocortisoneTITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONEAlumier Labs2551d748-c3d6-cd18-e063-6294a90adab62024-10-25WarningsExact identifier
application number: M020
TiZO Mineral Stick Non-Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDe7044f18-992a-4f60-9a2b-f11ed06db09b2024-10-25WarningsExact identifier
application number: M020
CoTZ Lip BalmTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD479a7d82-a068-4c2e-b50b-555c40e13e372024-10-25WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.e17a8c35-2d49-4c99-b154-ea673c14753e2024-10-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83154-003-018315400030125 g in 1 CONTAINER25 gHistorical
83154-003-02831540003021 CONTAINER in 1 CARTON (83154-003-02) / 25 g in 1 CONTAINER (83154-003-01) 1 container2024-02-03NoNoCurrent
83154-003-03831540003038 g in 1 CONTAINER8 gHistorical
83154-003-04831540003041 CONTAINER in 1 CARTON (83154-003-04) / 8 g in 1 CONTAINER (83154-003-03) 1 container2024-02-03NoNoCurrent
83154-003-058315400030515 g in 1 CONTAINER15 gHistorical
83154-003-06831540003061 CONTAINER in 1 CARTON (83154-003-06) / 15 g in 1 CONTAINER (83154-003-05) 1 container2026-02-05NoNoCurrent
83154-003-078315400030725 g in 1 CONTAINER25 gHistorical
83154-003-08831540003081 CONTAINER in 1 POUCH (83154-003-08) / 25 g in 1 CONTAINER (83154-003-07) 1 container2026-04-16NoNoCurrent
83154-003-098315400030915 g in 1 CONTAINER15 gHistorical
83154-003-10831540003101 CONTAINER in 1 POUCH (83154-003-10) / 15 g in 1 CONTAINER (83154-003-09) 1 container2026-04-16NoNoCurrent