Indications and uses
Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Cream
- Manufacturer
- Oxygen Development LLC
- Effective date
- 2023-07-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:55:30
Label at a glance#
ProductCream
Active ingredientZINC OXIDE
Label structure12 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Apply to all skin exposed to the sun. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a board-spectrum SPF value of 15 or higher and other sun protection measures inclu...
Label contents#
Full prescribing information#
Active ingredient
Zinc Oxide 18.8%
Purpose
Sunscreen
Uses
Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
For external use only
Do not use
Do not use on damaged or broken skin
When using this product
Keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor
Stop use and ask a doctor if rash occurs
Keep out of reach of children
If product is swallowed, get medical help or contact a poison control center right away
Directions
Apply liberally 15 minutes before sun exposure.
Apply to all skin exposed to the sun.
Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating.
Sun protection measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a board-spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear a long-sleeved shirt, pants, hat, and sunglasses
Inactive Ingredient
Water, Dodecane, Coco-Caprylate, Tricaprylin, Brassica Napus Extract, Coconut Alkanes, Simmondsia Chinensis (Jojoba) Seed Oil, Stearalkonium Bentonite, Polyglyceryl-3 Polyricinoleate, Oryza Sativa (Rice) Bran Extract, Propanediol, Caprylic/Capric Triglyceride, Glyceryl Caprylate, Coco-Caprylate/Caprate, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone, Cocos Nucifera (Coconut) Oil, Citrus Limon (Lemon) Peel Oil, Citrus Aurantofolia (Lime) Oil, Citrus Aurantium Bergamia (Bergamot)Fruit Oil, Tremella Fucformis Sporocarp Extract, Camelia Sinensis Leaf Extract, Linoleic Acid, Lecithin, Limnanther Alba (Meadowfoam (Speed Oil, Crambe Abyssinica Seed Oil, Camelia Oleifera Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil, Phytosteryl Canola Glycerides, Oleic Acid, Palmitic Acid, Stearic Acid, Triolein, Tocopherol, Adansonia Digitata Oil, Maurita Flexuosa Fruit Oil, Gardenia Taitensis Flowe Extract, Moringa Oleifera Seed Oil, Caryocar Brasiliense Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Extract, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Tocopherol Acetate, Ulva Lactuca Extract, Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Triethyl Citrate, Glycerin, Betain, Glyceryl Undecylenate, Potassium Sorbate, Sodium Benzoate, Bentonite, May Contain: Titanium Dioxide (CI 77492), Iron Oxides (CI 77491, CI 77492, CI 77499)
Other Information
Protect the product in this container from excessive heat and direct sun
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 124351b2-6dbf-42d0-9ea7-f0e299215f9a | Product name | 1 | 20210115 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-114-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8e75-d83d-e063-dadaa90ab31f | MONAT BB CREAM SPF 40 Broad-Spectrum Moisturizer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-114-01 | Cream | 100 mg in 1 TUBE | CREAM | 100 | 1 | |
| 61354-114-01 | Cream | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cream
- zinc oxide
- TRICAPRYLIN
- JOJOBA OIL
- POLYGLYCERYL-3 PENTARICINOLEATE
- RICE BRAN
- COCO-CAPRYLATE
- POLYGLYCERYL-3 DIISOSTEARATE
- DIMETHICONE
- TRIHEPTANOIN
- WATER
- STEARALKONIUM ION
- BENTONITE
- DODECANE
- BRASSICA NAPUS WHOLE
- GLYCERYL CAPRYLATE
- MAGNESIUM SULFATE, UNSPECIFIED
- PROPANEDIOL
- POLYHYDROXYSTEARIC ACID STEARATE
- MEDIUM-CHAIN TRIGLYCERIDES
- COCO-CAPRYLATE/CAPRATE
- TRIETHYL CITRATE
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-114 | 61354-114-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| ffe8d444-454c-bd49-e053-6294a90ad20f | ffe94015-dd30-d0fd-e053-6294a90a2a84 | 2023-07-07 | Warnings | ffe8d444-454c-bd49-e053-6294a90ad20f ffe94015-dd30-d0fd-e053-6294a90a2a84 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.