AMOREPACIFIC
- Product NDC
- 43419-511
- 11-digit product format
- 434190511
- Labeler code
- 43419
- Product ID
- 43419-511_23f8e489-0a6a-f321-e063-6294a90a5de0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- AMOREPACIFIC CORPORATION
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-12-05
- Substance
- OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 1.05; .6225; 1.47 g/15g; g/15g; g/15g
- 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
- AMOREPACIFIC
- Brand name suffix
- COLOR CONTROL CUSHION COMPACT NO.104
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 1.05 g/15g |
| TITANIUM DIOXIDE | .6225 g/15g |
| ZINC OXIDE | 1.47 g/15g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60964d9f-d96c-4397-b273-6b63d1886722 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43419-511-21 | AMOREPACIFICCOLOR CONTROL CUSHION COMPACT NO.104 | 2 in 1 CARTON | LOTION | 2 | 11 | |
| 43419-511-21 | AMOREPACIFICCOLOR CONTROL CUSHION COMPACT NO.104 | 15 g in 1 CONTAINER | LOTION | 15 | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43419-511 | AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.106 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.208 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.204 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [AMOREPACIFIC CORPORATION] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241010_60964d9f-d96c-4397-b273-6b63d1886722.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PRO-TECT SPORTS SUNSCREEN | MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE | Bio-Medical & Pharmaceutical Manufacturing Corporation | 66bb06fb-33d2-4b57-a65f-66bcd187c627 | 2025-12-03 | Warnings | M020 |
| PRO-TECT SUNSCREEN FOR PROFESSIONALS | MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE | Bio-Medical & Pharmaceutical Manufacturing Corporation | 374e172b-90e8-4fca-8934-dee3ed7b599d | 2025-12-03 | Warnings | M020 |
| LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL | OCTINOXATE, ZINC OXIDE | BEL STAR S A | 25b6cb46-6516-376a-e063-6394a90a44f6 | 2025-12-03 | Warnings | M020 |
| LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | BEL STAR SA | 4510cd0d-40b8-f452-e063-6394a90a44e5 | 2025-12-03 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 45117885-c674-b58a-e063-6394a90af5f4 | 2025-12-03 | Warnings | M020 |
| CANNON BALM | OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | DUKE CANNON SUPPLY CO. | f70a0173-c8ba-da7c-e053-6294a90a67db | 2025-12-03 | Warnings | M020 |
| CANNON BALM 140 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | DUKE CANNON SUPPLY CO. | f70c8632-ed11-0cc3-e053-6394a90a77db | 2025-12-03 | Warnings | M020 |
| Omega-Boost Sheer Mineral Sunscreen | MINERAL SUNSCREEN | Trilogy Natural Products Limited | 0405b7a6-6885-ed93-e063-6294a90a9386 | 2025-12-03 | Warnings | M020 |
| Poolside Hot Head SPF 30 hair scalp sunscreen mist | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4517da75-c91a-1f93-e063-6394a90a65ac | 2025-12-03 | Warnings | M020 |
| Poolside Tropic Touch SPF 30 Sunscreen Body spray. | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4517ef95-8ea1-3de6-e063-6394a90a2c79 | 2025-12-03 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen oil mist | HOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3% | Longway Technology(Guangzhou)Co.,Ltd. | 4517fd05-ea60-0492-e063-6294a90a28e9 | 2025-12-03 | Warnings | M020 |
| e.l.f. All Set For Sun SPF 45 Sunscreen | AVOBENZONE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 26f43446-e5ee-57a5-e063-6394a90a8661 | 2025-12-03 | Warnings | M020 |
| Banana Boat | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 7678467a-9da3-1b51-e053-2991aa0a568f | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | CARDINAL HEALTH, INC. | b60cf360-7c8d-5da4-e053-2995a90a24c2 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b6107d22-a992-eaa1-e053-2995a90a29c2 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b623defb-4a9d-6fc5-e053-2995a90ae846 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b62329d7-29e9-d111-e053-2a95a90aab06 | 2025-12-02 | Warnings | M020 |
| Leader Ultra Sheer SPF 100 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CARDINAL HEALTH, INC. | b5a467e0-a6ab-4136-8101-f22cc319de58 | 2025-12-02 | Warnings | M020 |
| Leader General Protection SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | 9544b046-055e-5886-e053-2a95a90ad09e | 2025-12-02 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 44fe0844-cb74-7a04-e063-6294a90aca15 | 2025-12-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43419-511-21 | 43419051121 | 2 CONTAINER in 1 CARTON (43419-511-21) / 15 g in 1 CONTAINER | 2 container | 2012-12-05 | 0000-00-00 | No | No | Current |