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NDC 13734-0157-61 NARS SMOOTH and PROTECT PRIMER 741.7; 2967; 1483.5; 1483.5; 1483.5 mg/30mL; mg/30mL; mg/30mL; mg/30mL; mg/30mL Details
NARS SMOOTH and PROTECT PRIMER 741.7; 2967; 1483.5; 1483.5; 1483.5 mg/30mL; mg/30mL; mg/30mL; mg/30mL; mg/30mL
NARS SMOOTH and PROTECT PRIMER is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by NARS Cosmetics. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.
Product Information
| NDC | 13734-0157 |
|---|---|
| Product ID | 13734-157_35748dc1-2591-49b2-938d-047e210c0c7b |
| 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 | NARS SMOOTH and PROTECT PRIMER |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 741.7; 2967; 1483.5; 1483.5; 1483.5 |
| Active Ingredient Units | mg/30mL; mg/30mL; mg/30mL; mg/30mL; mg/30mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE |
| Labeler Name | NARS Cosmetics |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 13734-0157-61 (13734015761)
| NDC Package Code | 13734-157-61 |
|---|---|
| Billing NDC | 13734015761 |
| Package | 1 mL in 1 PACKET (13734-157-61) |
| Marketing Start Date | 2016-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d36f9c8f-3b59-4e00-a541-0f779f552c64 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
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply 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 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
- children under 6 months: Ask a doctor
Inactive ingredients
Dimethicone ∙ Methyl Trimethicone ∙ Dimethicone/Vinyl Dimethicone Crosspolymer ∙ Dimethicone Crosspolymer ∙ Disteardimonium Hectorite ∙ Polymethylsilsesquioxane ∙ Silica ∙ Trimethylsiloxysilicate ∙ HDI/Trimethylol Hexyllactone Crosspolymer ∙ PEG-10 Dimethicone ∙ PEG/PPG-19/19 Dimethicone ∙ Hydrogenated Polyisobutene ∙ Tocopherol ∙ Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer ∙ VP/Eicosene Copolymer ∙ Dipropylene Glycol ∙ Water ∙ Lavandula Angustifolia (Lavender) Extract ∙ Dimethylmethoxy Chromanol ∙ Trisodium EDTA ∙ Tin Oxide ∙ Mica ∙ Titanium Dioxide ∙
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
INGREDIENTS AND APPEARANCE
| NARS SMOOTH AND PROTECT PRIMER
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream |
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| Labeler - NARS Cosmetics (837363571) |
Revised: 11/2018
Document Id: 35748dc1-2591-49b2-938d-047e210c0c7b
Set id: d36f9c8f-3b59-4e00-a541-0f779f552c64
Version: 2
Effective Time: 20181126