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NDC 73088-0107-16 Mineral Mist 3.4; 15.7 g/100mL; g/100mL Details
Mineral Mist 3.4; 15.7 g/100mL; g/100mL
Mineral Mist is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by TUBBY TODD. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
| NDC | 73088-0107 |
|---|---|
| Product ID | 73088-107_dca549a9-0c36-2924-e053-2a95a90a98fc |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Mineral Mist |
| Proprietary Name Suffix | SPF-50 |
| Non-Proprietary Name | TITANIUM DIOXIDE, ZINC OXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | TOPICAL |
| Active Ingredient Strength | 3.4; 15.7 |
| Active Ingredient Units | g/100mL; g/100mL |
| Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
| Labeler Name | TUBBY TODD |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 73088-0107-16 (73088010716)
| NDC Package Code | 73088-107-16 |
|---|---|
| Billing NDC | 73088010716 |
| Package | 178 mL in 1 BOTTLE (73088-107-16) |
| Marketing Start Date | 2022-04-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL dca54a19-af25-ce47-e053-2a95a90a22db Details
USES
WARNINGS
• For external use only.
• Do not use on damaged or broken skin.
• Stop use and ask a doctor if rash occurs.
• When using this product keep out of eyes. Rinse with water to remove.
Do not spray product directly on face. Spray onto hands and rub onto face.
Do not inhale spray.
- Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
SPL UNCLASSIFIED SECTION
DIRECTIONS
- Apply generously 15 minutes before sun exposure and as needed.
- Reapply
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Children under 6 months of age: ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am-2pm
- wear long-sleeved shirts, pants, hats, and sunglasses.
INACTIVE INGREDIENT
ALOE BARBADENSIS LEAF JUICE, ALUMINA, BENTONITE, BISABOLOL, BUTYLOCTYL SALICYLATE, C18-21 ALKANE, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CELLULOSE GUM, CETEARYL ALCOHOL, CITRIC ACID, COCO-GLUCOSIDE, DICAPRYLYL CARBONATE, GLYCERIN, ISOCETYL STEAROYL STEARATE, ISONONYL ISONONANOATE, METHYL DIHYDROABIETATE, MICROCRYSTALLINE CELLULOSE, MUSA SAPIENTUM (BANANA) FRUIT EXTRACT, POLYESTER-8, POLYHYDROXYSTEARIC ACID, PROPANEDIOL, SILICA, SODIUM GLUCONATE, SODIUM STEAROYL GLUTAMATE, TOCOPHEROL, WATER
INGREDIENTS AND APPEARANCE
| MINERAL MIST
SPF-50
titanium dioxide, zinc oxide spray |
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| Labeler - TUBBY TODD (052545299) |
Revised: 4/2022
Document Id: dca549a9-0c36-2924-e053-2a95a90a98fc
Set id: dca54a19-af25-ce47-e053-2a95a90a22db
Version: 1
Effective Time: 20220414