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 |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| Intensive Age Defying Hydrating Complex SPF 25 | HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE | June Jacobs Labs, LLC | 18f59d9d-1328-d815-e063-6294a90a3801 | 2024-05-21 | Warnings | M020 |
| Advanced Sun Resistance SPF 30 | HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE | June Jacobs Labs, LLC | 18f879f0-3d5b-0067-e063-6394a90a9db3 | 2024-05-21 | Warnings | M020 |
| Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs LLC | 18e1edd9-e39b-c91f-e063-6394a90a32a0 | 2024-05-20 | Warnings | M020 |
| Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs, LLC | 18e4c50d-eb91-c269-e063-6394a90a7999 | 2024-05-20 | Warnings | M020 |
| Broad Spectrum SPF 30 Tropical Sunscreen | BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN | Raining Rose, Inc | 18e7fc6b-b40a-f790-e063-6294a90ad0f4 | 2024-05-20 | Warnings | M020 |
| Protectif Untinted | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 18aa2604-c8f0-ca04-e063-6294a90a1c25 | 2024-05-17 | Warnings | M020 |
| Vacation Shimmer Oil | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | Vacation Inc | 150cbb23-fcb9-ed6f-e063-6394a90a597c | 2024-05-16 | Warnings | M020 |
| Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | d66dfcec-ad40-3a0b-e053-2995a90aa006 | 2024-05-14 | Warnings | M020 |
| Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | d66c88a1-7684-1043-e053-2a95a90aa2aa | 2024-05-14 | Warnings | M020 |
| Jack Black | TITANIUM DIOXIDE, ZINC OXIDE | Jack Black L.L.C | 181d5bf3-ce91-cb2c-e063-6294a90a51c4 | 2024-05-10 | Warnings | M020 |
| Protectif Fair Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 181e3f34-c5b2-0976-e063-6394a90a9a78 | 2024-05-10 | Warnings | M020 |
| SABIYA Broad Spectrum SPF-30 | ZINC OXIDE | SABIYA, LLC | bc403672-7576-49a6-9a29-4f6cb19af7a4 | 2024-05-09 | Warnings | M020 |
| SABIYA Broad Spectrum SPF-50 | ZINC OXIDE | SABIYA, LLC | 4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c | 2024-05-09 | Warnings | M020 |
| Protectif Deep Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 180b2939-5ae4-88fb-e063-6394a90aad93 | 2024-05-09 | Warnings | M020 |
| UV Daily Deep Tint | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc. | c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b450 | 2024-05-09 | Warnings | M020 |
| Chemical Sunscreen SPF50 | OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREEN | Swiss-American CDMO, LLC | 50f47495-93aa-4e11-a153-d4c847a36c99 | 2024-05-08 | Warnings | M020 |
| UV Clear Deep Tint | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc. | ead07d51-9400-4f0a-8966-7052dfae67bc | 2024-05-08 | Warnings | M020 |
| Essence Pout Protector SPF 20 Lip Balm | HOMOSALATE, OCTISALATE, ZINC OXIDE | cosnova GmbH | 17e483c5-6e47-9a50-e063-6394a90aa604 | 2024-05-07 | Warnings, Adverse reactions | M020 |
| MIRABELLA Broad Spectrum SPF 30 Sunscreen | HOMOSALATE, OCTISALATE, AVOBENZONE | GDM ENTERPRISES LLC | 3ac847d5-a75d-4b32-84e1-70e4282c0d72 | 2024-05-06 | Warnings | M020 |
| MELAN SPF-30 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE | MELAN INC. | 75fcef12-bc33-44a7-acda-77d5d7bca2bc | 2024-05-02 | 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 |