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NDC 73517-0125-01 SQUALANE ZINC SHEER MINERAL SUNSCREEN 140 mg/mL Details
SQUALANE ZINC SHEER MINERAL SUNSCREEN 140 mg/mL
SQUALANE ZINC SHEER MINERAL SUNSCREEN is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Amyris, Inc. The primary component is ZINC OXIDE.
Product Information
| NDC | 73517-0125 |
|---|---|
| Product ID | 73517-125_d509651b-4af5-8ae8-e053-2a95a90a042a |
| 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 | SQUALANE ZINC SHEER MINERAL SUNSCREEN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SQUALANE ZINC SHEER MINERAL SUNSCREEN |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 140 |
| Active Ingredient Units | mg/mL |
| Substance Name | ZINC OXIDE |
| Labeler Name | Amyris, 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 73517-0125-01 (73517012501)
| NDC Package Code | 73517-125-01 |
|---|---|
| Billing NDC | 73517012501 |
| Package | 50 mL in 1 TUBE (73517-125-01) |
| Marketing Start Date | 2020-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a525b24e-4ced-d47a-e053-2a95a90ad678 Details
Uses Warnings Directions
Helps prevent sunburn
if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early signs of aging caused by the sun
Warnings
For external use only
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 if rash occurs
Keep out of reach of children if product is swallwed get medical help or contact Poison Control Center right away
Directions
apply generously 15 minutes before sun exposure. reapply at least every 2 hours
Sun Protection Measures
Spendign 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 value of SPF 15 or higher and other sun protections measures including: limit time in the sun, especially from 10 am - 2pm
wear long-sleeved shirts, pants, hats, and sunglasses
use a water resistant sunscreen if swimming or sweating
children under 6 months of age ask a doctor.
Inactive Ingredients:
Inactive Ingredients: Water, Caprylic/Capric Triglyceride, Squalane, Glycerin, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Coco-Glucoside, Cetyl Palmitate, Polyglyceryl-3 Polyricinoleate, Caprylyl/Capryl Glucoside, Nymphaea Alba Flower Extract, Acacia Senegal Gum, Ethyl Ferulate, Xanthan Gum, Sodium Gluconate, Lecithin, Sodium Palmitoyl Proline, Polyhydroxystearic Acid, Ethylhexylglycerin, Phenoxyethanol, Isostearic Acid.
INGREDIENTS AND APPEARANCE
| SQUALANE ZINC SHEER MINERAL SUNSCREEN
squalane zinc sheer mineral sunscreen cream |
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| Labeler - Amyris, Inc (185930182) |