Search by Drug Name or NDC
NDC 82086-0002-34 Red Gecko Broad Spectrum SPF 30 Sunscreen 18 g/100mL Details
Red Gecko Broad Spectrum SPF 30 Sunscreen 18 g/100mL
Red Gecko Broad Spectrum SPF 30 Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Formula 7venz L.L.C.. The primary component is ZINC OXIDE.
Product Information
| NDC | 82086-0002 |
|---|---|
| Product ID | 82086-002_cc00fc1a-8e0a-4a9e-8d03-005ab129dd0f |
| 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 | Red Gecko Broad Spectrum SPF 30 Sunscreen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 18 |
| Active Ingredient Units | g/100mL |
| Substance Name | ZINC OXIDE |
| Labeler Name | Formula 7venz L.L.C. |
| 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 82086-0002-34 (82086000234)
| NDC Package Code | 82086-002-34 |
|---|---|
| Billing NDC | 82086000234 |
| Package | 100 mL in 1 TUBE (82086-002-34) |
| Marketing Start Date | 2020-07-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 05bcce73-8ea2-499c-9752-d96b7c5707a0 Details
Uses
Warnings
Directions
• Apply liberally and evenly 15 minutes prior to sun exposure
• Reapply: After 40 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 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredients
Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, helianthus annuus (sunflower) seed
oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl
alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis
leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit
extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN
zinc oxide lotion |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler - Formula 7venz L.L.C. (118069729) |