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NDC 69840-0028-19 Yes To Tomatoes Fragrance-Free Clarifying Mineral Broad Spectrum SPF-30 157 mg/mL Details
Yes To Tomatoes Fragrance-Free Clarifying Mineral Broad Spectrum SPF-30 157 mg/mL
Yes To Tomatoes Fragrance-Free Clarifying Mineral Broad Spectrum SPF-30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Yes To, Inc.. The primary component is ZINC OXIDE.
Product Information
| NDC | 69840-0028 |
|---|---|
| Product ID | 69840-028_602118bb-56ac-4b09-bb77-7354f0fe906c |
| 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 | Yes To Tomatoes Fragrance-Free Clarifying Mineral Broad Spectrum SPF-30 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc Oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 157 |
| Active Ingredient Units | mg/mL |
| Substance Name | ZINC OXIDE |
| Labeler Name | Yes To, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 69840-0028-19 (69840002819)
| NDC Package Code | 69840-028-19 |
|---|---|
| Billing NDC | 69840002819 |
| Package | 50 mL in 1 TUBE (69840-028-19) |
| Marketing Start Date | 2022-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 89a37969-bb8b-46a5-8975-9a207957fbe0 Details
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
Directions
- apply generously and evenly 15 minutes before sun exposure.
- 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 10 a.m.–2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating.
Inactive Ingredients
Water (Aqua), Cocos Nucifera (Coconut) Oil, Diisooctyl Succinate, Tetradecane, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Butyrospermum Parkii (Shea) Butter, Solanum Lycopersicum (Tomato) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Extract, Calcium Sodium Borosilicate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Coco-Glucoside, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Squalane, Bisabolol, Tocopherol, Glycerin, Sodium Gluconate, Xanthan Gum, Citric Acid, Alcohol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Caprylyl Glycol, Caprylhydroxamic Acid.
PRINCIPAL DISPLAY PANEL - 50 mL Tube Label
INGREDIENTS AND APPEARANCE
| YES TO TOMATOES FRAGRANCE-FREE CLARIFYING MINERAL BROAD SPECTRUM SPF-30
zinc oxide cream |
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| Labeler - Yes To, Inc. (788689680) |
Revised: 1/2022
Document Id: 602118bb-56ac-4b09-bb77-7354f0fe906c
Set id: 89a37969-bb8b-46a5-8975-9a207957fbe0
Version: 1
Effective Time: 20220126