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NDC 54108-0423-01 Sun Defense Mineral Oil-Free Sunscreen SPF 30 Baby 200 mg/g Details
Sun Defense Mineral Oil-Free Sunscreen SPF 30 Baby 200 mg/g
Sun Defense Mineral Oil-Free Sunscreen SPF 30 Baby is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by derma e. The primary component is ZINC OXIDE.
Product Information
| NDC | 54108-0423 |
|---|---|
| Product ID | 54108-0423_7145ce51-094b-480e-b624-a98e8a564664 |
| 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 | Sun Defense Mineral Oil-Free Sunscreen SPF 30 Baby |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc Oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/g |
| Substance Name | ZINC OXIDE |
| Labeler Name | derma e |
| 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 54108-0423-01 (54108042301)
| NDC Package Code | 54108-0423-1 |
|---|---|
| Billing NDC | 54108042301 |
| Package | 1 TUBE in 1 CARTON (54108-0423-1) / 113 g in 1 TUBE |
| Marketing Start Date | 2016-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7bf508d2-7b56-496f-a081-6a04d7f4a8cd 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 liberally 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
Inactive Ingredients
Purified Water, Coco-Caprylate (Coconut Derived), Dicaprylyl Carbonate, Lauryl Glucoside (Plant Derived), Polyglyceryl-2 Dipolyhydroxystearate, Glycerin (Vegetable Derived), Microcrystalline Cellulose (Plant Derived), Cellulose Gum (Plant Derived), Organic Camellia Sinensis (Green Tea) Leaf Extract1, Chamomilla Recutita (Matricaria) Flower Extract, Calendula Officinalis Flower Extract, Panthenol (Provitamin B5), Sodium Ascorbyl Phosphate (Vitamin C), Tocopheryl Acetate (Vitamin E), Phytic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Xanthan Gum, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol.
- 1
- Certified Organic Ingredients
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
INGREDIENTS AND APPEARANCE
| SUN DEFENSE MINERAL OIL-FREE SUNSCREEN SPF 30 BABY
zinc oxide cream |
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| Labeler - derma e (148940450) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Topiderm, Inc. | 049121643 | MANUFACTURE(54108-0423) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Topix Pharmaceuticals Inc | 613171433 | PACK(54108-0423) | |
Revised: 7/2021
Document Id: 7145ce51-094b-480e-b624-a98e8a564664
Set id: 7bf508d2-7b56-496f-a081-6a04d7f4a8cd
Version: 3
Effective Time: 20210715