Untinted Sheer Defense
- Product NDC
- 85516-202
- 11-digit product format
- 855160202
- Labeler code
- 85516
- Product ID
- 85516-202_46042d20-dc41-fe77-e063-6394a90a94aa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Kristina Lerner
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-05
- Substance
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 38; 80 mg/g; mg/g
- 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
- Untinted Sheer Defense
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 38 mg/g |
| TITANIUM DIOXIDE | 80 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 35be50b7-a9af-29ee-e063-6394a90a45ba | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85516-202-50 | Untinted Sheer Defense | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| SOLMED SUNSCREEN FACE SHIELD | AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE | FEELFREE LLC | 31b077cc-32b9-78e6-e063-6394a90a155a | 2025-03-31 | Warnings | M020 |
| TATCHA THE SILK SUNSCREEN | ZINC OXIDE | TATCHA INC. | 7799042a-d2de-480e-a8a3-827b3dc27907 | 2025-03-31 | Warnings | M020 |
| Cotz Sensitive SPF 40 Sunscreen | ZINC OXIDE | Fallien Cosmeceuticals, LTD. | 885a674b-3457-4dfe-a801-529094b00499 | 2025-03-31 | Warnings | M020 |
| EltaMD UV Daily Tinted | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | ad8aafdf-f3bc-497f-9792-20c2911c12d0 | 2025-03-31 | Warnings | M020 |
| EltaMD UV Clear Tinted SPF46 | ZINC OXIDE AND OCTINOXATE SUNSCREEN | CP Skin Health Group, Inc. | 1ac59ef1-113e-4ad1-90c3-38353bc7e1ec | 2025-03-31 | Warnings | M020 |
| lip balm SPF15( CB222) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316416d0-52b5-6f2f-e063-6294a90a9bc1 | 2025-03-28 | Warnings | M020 |
| lip balm SPF15( CB400) 01 | OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316463e0-dc1f-e2ae-e063-6394a90a0c3c | 2025-03-28 | Warnings | M020 |
| Sunscreen Stick SPF30( CB400) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 316498d9-32fe-f884-e063-6394a90a4307 | 2025-03-28 | Warnings | M020 |
| ALEX MD PHD Sheer Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | PHYSICIAN LABORATORIES INC | 8f64c4fa-92ee-4af0-ab1b-6c3673f9a622 | 2025-03-28 | Warnings | M020 |
| ALEX MD PHD Tinted Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | PHYSICIAN LABORATORIES INC | 93873c34-5c72-43c8-b6c2-c65b596191d7 | 2025-03-28 | Warnings | M020 |
| TRADER JOES SHIMMER GLOW SUNSCREEN SPF 40 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Trader Joe's Company | 316c7793-5937-9ce4-e063-6294a90ae0a1 | 2025-03-28 | Warnings | M020 |
| CeraVe AM Facial Moisturizing Broad Spectrum SPF 50 Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE | L'Oreal USA Products Inc | dc85cff3-df18-4bb7-8d71-bb0878959fe2 | 2025-03-28 | Warnings | M020 |
| City Skin Age Defense Broad Spectrum SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Murad, LLC | f8c572a2-b4bc-49e9-95df-359f05bd69b7 | 2025-03-28 | Warnings | M020 |
| HEB SPF 50 Rejuvenate Sunscreen with Moisturizing Oils and Vitamins Continuous Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | H.E.B | 314c54ed-32f8-5c20-e063-6394a90a0af5 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( blueberry) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 314f8990-4b33-e2b1-e063-6394a90a4d79 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( bubble gum) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31507a62-09a7-6bcc-e063-6394a90aa575 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Birthday cake) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3152bd5d-474f-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Bubble Gum Flavored | LIP BALM SPF15 BUBBLE GUM FLAVORED | LS Promotions Inc | 3152bd5d-4750-e392-e063-6294a90aa930 | 2025-03-27 | Warnings | M020 |
| natural lip balm SPF15( Cocount Pina Colada) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 31538f32-9f71-bd40-e063-6394a90a1cd8 | 2025-03-27 | Warnings | M020 |
| Lip Balm SPF15 Birthday Cake flavored | LIP BALM SPF15 BIRTHDAY CAKE FLAVORED | LS Promotions Inc | 3153bc6a-8f60-ea37-e063-6294a90acd97 | 2025-03-27 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85516-202-50 | 85516020250 | 53 g in 1 BOTTLE, PUMP (85516-202-50) | 53 g | 2025-05-05 | No | No | Current |