Home NDC 83154-003 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.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 232 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TiZO Ultra Zinc SPF 40 (Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD 2d0856cf-d3da-5a77-e063-6294a90ad5b4 2025-01-31 Warnings Exact identifier application number: M020 FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 ZINC OXIDE Peer Pharm Ltd. 2cd83c55-851c-089e-e063-6294a90ad6bc 2025-01-30 Warnings Exact identifier application number: M020 FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 ZINC OXIDE Peer Pharm Ltd. 2cd958a3-bad6-725e-e063-6294a90a8578 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30 ZINC OXIDE Peer Pharm Ltd. 2cd77d62-77df-f3a9-e063-6394a90ad57d 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30 ZINC OXIDE Peer Pharm Ltd. 2caf3b6b-3a05-b24a-e063-6394a90a4799 2025-01-30 Warnings Exact identifier application number: M020 Jil Goorman Skincare Sun Guard SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SAN DIEGO NATURAL SOAP COMPANY 9a088bed-3b85-4bf5-923b-4c99eb904a8d 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 ZINC OXIDE Peer Pharm Ltd. 2baf0278-7e13-4db0-e063-6294a90ae9de 2025-01-30 Warnings Exact identifier application number: M020 Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc. 08a175ae-2307-ef8d-e063-6394a90ad234 2025-01-30 Warnings Exact identifier application number: M020 Babo Botanicals Super Shield Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc 08b7bcfd-0c7c-a14f-e063-6294a90a7797 2025-01-30 Warnings Exact identifier application number: M020 Salt and Stone Sunscreen Lip Balm SPF 30 ZINC OXIDE Salt and Stone LLC b555aa10-1547-63cc-e053-2995a90ad20d 2025-01-30 Warnings Exact identifier application number: M020 COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIR OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE Bluemercury 5c590aed-d2f2-4478-8919-37c848752b42 2025-01-29 Warnings Exact identifier application number: M020 LiProtect SPF 35 ZINC OXIDE, TITANIUM DIOXIDE Science of Skincare 0d0a2657-4098-3c60-e063-6294a90acabb 2025-01-29 Warnings Exact identifier application number: M020 Perfect Sunscreen Tinted Mineral SPF50 ZINC OXIDE Bluemercury, Inc. 4c978154-679f-472a-95ab-56878c5c70cd 2025-01-29 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE BELLE MEDICAL LLC 2cdc69d3-2192-7a38-e063-6294a90a257f 2025-01-29 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Boxbar Beauty LLC 2d04c5e7-f3aa-873f-e063-6294a90a33d2 2025-01-29 Warnings Exact identifier application number: M020 SEAWEED BATH CO. Super Sheer Face Serum SPF-50 ZINC OXIDE The Seaweed Bath Co. a45b46f9-681f-4a8d-b561-165b995ccf80 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish Non-Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc62961-dcef-d7db-e063-6394a90a9ebd 2025-01-28 Warnings Exact identifier application number: M020 Every Sun Day Ultra-Sheer Priming Sunscreen Stick AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Have & Be Co., Ltd. 2b53aa68-9c05-1682-e063-6294a90a968c 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc73c4f-30ea-0a51-e063-6394a90ac9a4 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc84aba-006b-a78e-e063-6294a90ae040 2025-01-28 Warnings Exact identifier application number: M020
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