Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50
- Product NDC
- 53208-800
- 11-digit product format
- 532080800
- Labeler code
- 53208
- Product ID
- 53208-800_2c6c3748-418a-33ac-e063-6294a90adbca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ensulizole, Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- LG H&H Co., Ltd.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-04-27
- Substance
- TITANIUM DIOXIDE; ENSULIZOLE; OCTINOXATE; ZINC OXIDE; OCTISALATE
- Active strength
- 2.285; 1.75; 3.5; 5.825; 2.25 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53208-800-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53208-800-01 | 0efc9e666f02… | f202fb6c5f17… |
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
- Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 2.285 g/50mL |
| ENSULIZOLE | 1.75 g/50mL |
| OCTINOXATE | 3.5 g/50mL |
| ZINC OXIDE | 5.825 g/50mL |
| OCTISALATE | 2.25 g/50mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| 9YQ9DI1W42 | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a4364c8d-8b74-130e-e053-2995a90ad1c1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 77dc03a4-fbfc-e6a3-fe95-285bbae40d75 | Product name | 2 | 20250814 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53208-800-01 | Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 | 2 in 1 BOX | LOTION | 2 | 3 | |
| 53208-800-01 | Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 | 50 mL in 1 TUBE | LOTION | 50 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53208-800 | BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50 (ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LG H&H CO., LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250125_a4364c8d-8b74-130e-e053-2995a90ad1c1.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 |
|---|---|---|---|---|---|---|
| Softlips Salted Caramel, Candy Apple, Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 42cf4623-0eb8-455a-b374-8e17e9336b92 | 2024-12-17 | Warnings | M020 |
| Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 0338c078-695d-4d4e-9e90-5a8a98d49524 | 2024-12-17 | Warnings | M020 |
| Softlips Pearl Plus Vanilla | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 107bcaa9-4347-4979-be44-35183a9ee67e | 2024-12-17 | Warnings | M020 |
| Softlips Raspberry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | d18b4c19-0365-44ec-bea8-4328e537e0d8 | 2024-12-17 | Warnings | M020 |
| Softlips Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 03062f13-270d-49cf-8939-2349f12e9cba | 2024-12-17 | Warnings | M020 |
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | f733747a-ad1a-4222-baf1-69dcd90a3350 | 2024-12-17 | Warnings | M020 |
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97 | 2024-12-17 | Warnings | M020 |
| Softlips Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 8d55141d-5d6f-4eec-87dc-d3c808cf7a6a | 2024-12-17 | Warnings | M020 |
| Softlips Pearl | OCTINOXATE, OCTISALATE | The Mentholatum Company | 43e175b4-7a48-431e-bf27-9ce7dee53f5e | 2024-12-17 | Warnings | M020 |
| Softlips Oasis Watermelon Blackberry | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | e1213808-4dad-4fd0-871a-04bba094a3cc | 2024-12-17 | Warnings | M020 |
| Softlips Peppermint | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27 | 2024-12-17 | Warnings | M020 |
| Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | 7c8a4921-ae45-47fb-a64e-c72b1a386d0d | 2024-12-17 | Warnings | M020 |
| Mentholatum Medicated Lip Balm Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 6edb132d-bb67-4e6c-8e18-db0305073a71 | 2024-12-17 | Warnings | M020 |
| Mentholatum Medicated Lip Balm Original | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1 | 2024-12-17 | Warnings | M020 |
| Mentholatum Natural Ice Sport SPF 30 | AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 57c35631-42d3-4c6c-bcbb-e2de92b45b13 | 2024-12-17 | Warnings | M020 |
| Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Mary Kay Inc. | 5f09503e-c455-4ac2-8d07-e8e66c2daa32 | 2024-12-17 | Warnings | M020 |
| Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium | HOMOSALATE, OCTINOXATE, OXYBENZONE | Mary Kay Inc. | b5ca4bed-4f89-4020-a055-9d11f4cd5058 | 2024-12-17 | Warnings | M020 |
| Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep | HOMOSALATE, OCTINOXATE, OXYBENZONE | Mary Kay Inc. | e5fffd20-1d22-485a-9311-4cb4f9264f6f | 2024-12-17 | Warnings | M020 |
| Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep | HOMOSALATE, OCTINOXATE, OXYBENZONE | Mary Kay Inc. | 404990e4-9499-4186-b39d-afc31834d334 | 2024-12-17 | Warnings | M020 |
| Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep | HOMOSALATE, OCTINOXATE, OXYBENZONE | Mary Kay Inc. | 6028e210-a8a3-4d84-a462-16a414c31052 | 2024-12-17 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53208-800-01 | 53208080001 | 2 TUBE in 1 BOX (53208-800-01) / 50 mL in 1 TUBE | 2 tube | 2020-04-27 | 0000-00-00 | No | No | Current |