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NDC 62032-0140-34 SUN SHIELD BROAD SPECTRUM SPF 50 MATTE 100; 50; 165 mg/g; mg/g; mg/g Details
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE 100; 50; 165 mg/g; mg/g; mg/g
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Obagi Cosmeceuticals LLC. The primary component is HOMOSALATE; OCTISALATE; ZINC OXIDE.
Product Information
| NDC | 62032-0140 |
|---|---|
| Product ID | 62032-140_a2859154-a41c-472b-aced-7a77f609c2f2 |
| 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 SHIELD BROAD SPECTRUM SPF 50 MATTE |
| Proprietary Name Suffix | SUNSCREEN |
| Non-Proprietary Name | HOMOSALATE, OCTISALATE, and ZINC OXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 100; 50; 165 |
| Active Ingredient Units | mg/g; mg/g; mg/g |
| Substance Name | HOMOSALATE; OCTISALATE; ZINC OXIDE |
| Labeler Name | Obagi Cosmeceuticals LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62032-0140-34 (62032014034)
| NDC Package Code | 62032-140-34 |
|---|---|
| Billing NDC | 62032014034 |
| Package | 479 g in 1 BOTTLE, PUMP (62032-140-34) |
| Marketing Start Date | 2019-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 263ef8e8-e0c4-42e6-bb26-7581a437b35a Details
SPL UNCLASSIFIED SECTION
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
- 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 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: Ask a doctor
Other information
Inactive ingredients
Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
INGREDIENTS AND APPEARANCE
| SUN SHIELD BROAD SPECTRUM SPF 50 MATTE
SUNSCREEN
homosalate, octisalate, and zinc oxide lotion |
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| Labeler - Obagi Cosmeceuticals LLC (790553353) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Swiss American CDMO, LLC | 080170933 | MANUFACTURE(62032-140) | |
Revised: 9/2019
Document Id: a2859154-a41c-472b-aced-7a77f609c2f2
Set id: 263ef8e8-e0c4-42e6-bb26-7581a437b35a
Version: 2
Effective Time: 20190905