BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN
- Product NDC
- 85053-007
- 11-digit product format
- 850530007
- Labeler code
- 85053
- Product ID
- 85053-007_54fc80b7-8f6d-e2be-e063-6394a90a4b59
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- TITANIUM DIOXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Shantou Woodsleep Biotechnology Co., Ltd.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-24
- Substance
- PHENYLBENZIMIDAZOLE SULFONIC ACID; AVOBENZONE; TITANIUM DIOXIDE; OCTOCRYLENE
- Active strength
- 1; .75; 4.5; 1 mg/50mg; mg/50mg; mg/50mg; mg/50mg
- 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
- BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLBENZIMIDAZOLE SULFONIC ACID | 1 mg/50mg |
| AVOBENZONE | .75 mg/50mg |
| TITANIUM DIOXIDE | 4.5 mg/50mg |
| OCTOCRYLENE | 1 mg/50mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9YQ9DI1W42 | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 54fc80b7-8f6c-e2be-e063-6394a90a4b59 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Ceile tint PROTECT tinted serum SPF 50 Ivory | CEILE TINT PROTECT TINTED SERUM SPF 50 IVORY | LE COSMETICS INC | 58547809-3480-1032-e063-6294a90a04c6 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Deep | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEP | LE COSMETICS INC | 58549160-3594-9056-e063-6394a90abf7d | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Deep | CEILE TINT PROTECT TINTED SERUM SPF 50 DEEP | LE COSMETICS INC | 585498d4-b29c-9580-e063-6394a90adf1e | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Fair | CEILE TINT PROTECT TINTED SERUM SPF 50 FAIR | LE COSMETICS INC | 58545633-cb36-6611-e063-6394a90a1f07 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Light | CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT | LE COSMETICS INC | 5853ae6b-0eaf-e614-e063-6394a90ae91a | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Light Medium | CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUM | LE COSMETICS INC | 585473c3-3ee9-7d84-e063-6394a90abd33 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM | LE COSMETICS INC | 58547b48-251a-10eb-e063-6294a90ac95c | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Tan | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TAN | LE COSMETICS INC | 58547e38-ae84-82ee-e063-6394a90a27d6 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Tan | CEILE TINT PROTECT TINTED SERUM SPF 50 TAN | LE COSMETICS INC | 58548331-38cd-8668-e063-6394a90a3362 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Honey | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEY | LE COSMETICS INC | 5854861a-376d-8825-e063-6394a90a8aab | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Honey | CEILE TINT PROTECT TINTED SERUM SPF 50 HONEY | LE COSMETICS INC | 585488c5-fac5-212f-e063-6294a90a00ff | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Rich | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICH | LE COSMETICS INC | 585488af-d14f-8d71-e063-6394a90ac4f0 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Rich | CEILE TINT PROTECT TINTED SERUM SPF 50 RICH | LE COSMETICS INC | 58548e6d-9c82-249c-e063-6294a90a11ad | 2026-08-05 | Warnings | M020 |
| 12 Days of Derm-Loved Skincare | OCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE | Rodan & Fields | a13f0275-5add-4464-88d4-ff9823274325 | 2026-08-03 | Warnings | M020 |
| Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY | OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% | Lale Cosmetics LLC | 581fb0cd-c55d-d562-e063-6394a90a7f11 | 2026-08-03 | Warnings | M020 |
| Manyo Air Light Moisturizing Sunscreen SPF 50 | ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Manyo Factory Corp. | 86761577-a32c-41a2-a2e3-b339b1493701 | 2026-08-03 | Warnings | M020 |
| EltaMD UV Active | ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN | CP Skin Health Group, Inc | 39d16479-d491-4c19-aa11-674461687c7b | 2026-08-03 | Warnings | M020 |
| AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30 | OCTISALATE, OCTOCRYLENE, AVOBENZONE | AMBI Enterprises LLC | 99bbe9a2-bb57-4a33-b339-1649d4b319c8 | 2026-07-31 | Warnings | M020 |
| AMBI Even and Clear Facial Moisturizer SPF-30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | AMBI Enterprises LLC | 4701c0ba-4ceb-4d66-9f99-515ce33b4648 | 2026-07-31 | Warnings | M020 |
| Continuous Correction Cream | TITANIUM DIOXIDE | Baxter of California, LLC | 1cbcc648-f2e1-af60-e063-6294a90ad4bb | 2026-07-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85053-007-01 | 85053000701 | 50 mg in 1 BOX (85053-007-01) | 50 mg | 2026-06-24 | No | No | Current |