Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN
- Product NDC
- 71883-050
- 11-digit product format
- 718830050
- Labeler code
- 71883
- Product ID
- 71883-050_49d6e9be-72d7-1681-e063-6394a90a9d61
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octyl salicylate, Titanium dioxide, Zinc oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Oracle Cosmetic Co., Ltd.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-26
- Substance
- ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE; HOMOSALATE
- Active strength
- 6.35; 2.25; 1.1; 3.75 g/50mL; g/50mL; g/50mL; g/50mL
- 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
- Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 6.35 g/50mL |
| OCTISALATE | 2.25 g/50mL |
| TITANIUM DIOXIDE | 1.1 g/50mL |
| HOMOSALATE | 3.75 g/50mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 21424f78-f8d5-6a9b-e063-6294a90ab7dc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71883-050-01 | Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN | 50 mL in 1 TUBE | CREAM | 50 | 2 | |
| 71883-050-02 | Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN | 1 in 1 BOX | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71883-050 | DR.ORACLE AIR FIT DEFENSE SOOTHING SUNSCREEN (HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ORACLE COSMETIC CO., LTD.] | 1 | Current NDC, 2 package rows | 20240927_21424f78-f8d5-6a9b-e063-6294a90ab7dc.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 |
|---|---|---|---|---|---|---|
| Sunscreen ULTRA Broad Spectrum Equate | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | WAL-MART STORES INC. | 68524d2b-284c-4a69-9b0e-8d2ad80822e2 | 2024-10-16 | Warnings | M020 |
| Equate SPF 50 Ultra Sunscreen Continuous | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wal-Mart Stores Inc | 8fda6c78-1b39-6aa6-e053-2995a90a16a2 | 2024-10-16 | Warnings | M020 |
| Equate SPF 70 Ultra Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Wal-Mart Stores Inc | 8f24e301-3fce-f9e3-e053-2a95a90affe4 | 2024-10-16 | Warnings | M020 |
| Equate SPF 50 Ultra Zinc Sunscreen | OCTOCRYLENE, ZINC OXIDE | Wal-Mart Stores Inc | 8fdc0bad-8834-5b4a-e053-2a95a90a9fde | 2024-10-16 | Warnings | M020 |
| Equate SPF 50 Ultra Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wal-Mart Stores Inc | 8f02f297-5315-ced4-e053-2a95a90a8c7b | 2024-10-16 | Warnings | M020 |
| Equate SPF 70 Ultra Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Wal-Mart Stores Inc | 9b655e56-33e5-45a3-9174-356fc717e39d | 2024-10-16 | Warnings | M020 |
| Equate Sunscreen SPF 70 SPORT Broad spectrum | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE | Wal-Mart Stores Inc | e3181725-d04e-4a73-8871-9a1a9a11229c | 2024-10-16 | Warnings | M020 |
| Equate Sunscreen SPORT SPF 100 | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE | Walmart Stores Inc. | 4fc58cea-082a-4535-9c51-8e7dedc15be3 | 2024-10-16 | Warnings | M020 |
| Equate Sunscreen SPF 50 KIDS Broad Spectrum | TITANIUM DIOXIDE, ZINC OXIDE | WAL-MART STORES INC | 81cb6b2e-1ca3-4a83-a8df-9bfee61e79af | 2024-10-16 | Warnings | M020 |
| Equate Sunscreen SPF100 SPORT Broad Spectrum | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE | WAL-MART STORES INC | 1ce4839b-f693-4653-8fe2-444df76eb83c | 2024-10-16 | Warnings | M020 |
| Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50 | HOMOSALATE , OCTOCRYLENE, ZINC OXIDE | Wal-Mart Stores Inc | 0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c89 | 2024-10-16 | Warnings | M020 |
| EQUATE Sunscreen BABY Broad Spectrum SPF 50 | AVOBENZONE HOMOSALATE OCTOCRYLENE | WAL-MART STORES INC | b2083cbd-ef19-4edc-9d7d-eca3452ee0ee | 2024-10-16 | Warnings | M020 |
| Equate-Sunscreen Broad Spectrum SPF 50 ULTRA | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | Wal-Mart Stores Inc | bbe06f23-0d0f-43ff-9d1b-37a99d9d6206 | 2024-10-16 | Warnings | M020 |
| BIG LOTS SOUNDBODY SPF 50 SPORT SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BIG LOTS STORES, INC. | c8c1c904-12f5-48e0-e053-2a95a90a9f75 | 2024-10-16 | Warnings | M020 |
| Big Lots Soundbody SPF 70 Sport Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | BIG LOTS STORES, INC. | e717ec77-8beb-645a-e053-2a95a90ac11b | 2024-10-16 | Warnings | M020 |
| Big Lots Soundbody SPF 50 Ultra Sport Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | BIG LOTS STORES, INC. | f0dcb5d8-a3e5-4334-e053-2995a90a535a | 2024-10-16 | Warnings | M020 |
| Big Lots Soundbody SPF 30 Sport Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, | BIG LOTS STORES, INC. | c8aede4f-3d84-63d1-e053-2a95a90afb1a | 2024-10-16 | Warnings | M020 |
| Big Lots Soundbody SPF 70 Sun Defense | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | BIG LOTS STORES, INC. | db3ad809-d6c9-6c83-e053-2a95a90ac58b | 2024-10-16 | Warnings | M020 |
| BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BIG LOTS STORES, INC. | e4b70fdb-7548-175c-e053-2995a90adfe6 | 2024-10-16 | Warnings | M020 |
| BIOLUMIN-C HEAT AGING PROTECTOR SPF50 | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE | Dermalogica, LLC. | 38d0b78b-bd8e-4cb0-925a-19adff550c19 | 2024-10-16 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71883-050-01 | 71883005001 | 50 mL in 1 TUBE | 50 ml | Historical | |||
| 71883-050-02 | 71883005002 | 1 TUBE in 1 BOX (71883-050-02) / 50 mL in 1 TUBE (71883-050-01) | 1 tube | 2024-09-26 | No | No | Current |