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NDC 70170-0016-01 eos THE GUARDIAN 100% NATURAL SPF 30 WATERMELON SUN PROTECT SUNSCREEN LIP BALM 0.4 g/4g Details
eos THE GUARDIAN 100% NATURAL SPF 30 WATERMELON SUN PROTECT SUNSCREEN LIP BALM 0.4 g/4g
eos THE GUARDIAN 100% NATURAL SPF 30 WATERMELON SUN PROTECT SUNSCREEN LIP BALM is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by eos Products LLC. The primary component is ZINC OXIDE.
Product Information
| NDC | 70170-0016 |
|---|---|
| Product ID | 70170-0016_8d615bd1-38cb-4777-8f3b-b6a66442aa55 |
| 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 | eos THE GUARDIAN 100% NATURAL SPF 30 WATERMELON SUN PROTECT SUNSCREEN LIP BALM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc Oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | STICK |
| Route | TOPICAL |
| Active Ingredient Strength | 0.4 |
| Active Ingredient Units | g/4g |
| Substance Name | ZINC OXIDE |
| Labeler Name | eos Products LLC |
| 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 | 2024-12-31 |
Package
Package Images
NDC 70170-0016-01 (70170001601)
| NDC Package Code | 70170-0016-1 |
|---|---|
| Billing NDC | 70170001601 |
| Package | 1 CONTAINER in 1 BLISTER PACK (70170-0016-1) / 4 g in 1 CONTAINER |
| Marketing Start Date | 2021-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 64aed832-face-457b-9ceb-7f08f617971c Details
SPL UNCLASSIFIED SECTION
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply:
- after 80 minutes of swimming or sweating
- at least every 2 hours
- 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
- Children under 6 months of age: Ask a doctor.
Inactive ingredients
Beeswax (Cire D’abeille), Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Shea Butter Ethyl Esters, Jojoba Esters, Oryza Sativa (Rice) Bran Wax, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Wax, Butyrospermum Parkii (Shea) Butter, Prunus Persica (Peach) Flower Extract, Citrullus Lanatus (Watermelon) Seed Extract, Acacia Decurrens Flower Wax, Stevia Rebaudiana Leaf/Stem Extract, Tocopherol, Polyglycerin-3, Glycine Soja (Soybean) Oil, Glyceryl Isostearate, Polyhydroxystearic Acid, Glycerin, Water, Citric Acid, Limonene1, Linalool1. 1Component of flavor.
Principal Display Panel - 0.14 oz (4 g)
INGREDIENTS AND APPEARANCE
| EOS THE GUARDIAN 100% NATURAL SPF 30 WATERMELON SUN PROTECT SUNSCREEN LIP BALM
zinc oxide stick |
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| Labeler - eos Products LLC (803969620) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Dermaceutical Laboratories, LLC | 078457159 | manufacture(70170-0016) | |