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NDC 42851-0064-04 ZO Skin Health Broad-Spectrum Sunscreen SPF 50 7.552; 17.7 mg/118g; mg/118g Details
ZO Skin Health Broad-Spectrum Sunscreen SPF 50 7.552; 17.7 mg/118g; mg/118g
ZO Skin Health Broad-Spectrum Sunscreen SPF 50 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by ZO Skin Health, Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
NDC | 42851-0064 |
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Product ID | 42851-064_e81c7511-8433-1d43-e053-2a95a90a008e |
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 | ZO Skin Health Broad-Spectrum Sunscreen SPF 50 |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Titanium Dioxide, Zinc Oxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 7.552; 17.7 |
Active Ingredient Units | mg/118g; mg/118g |
Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
Labeler Name | ZO Skin Health, Inc. |
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 42851-0064-04 (42851006404)
NDC Package Code | 42851-064-04 |
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Billing NDC | 42851006404 |
Package | 1 TUBE in 1 CARTON (42851-064-04) / 118 g in 1 TUBE |
Marketing Start Date | 2022-08-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d817f80b-a998-b67e-e053-2995a90a1971 Details
Drug Facts
Active Ingredients
Active Ingredient | Purpose |
Titanium Dioxide 6.4% | Sunscreen |
Zinc Oxide 15.0% | Sunscreen |
Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
- 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
1,2-Hexanediol, Alumina, Aqua/Water/Eau, Ascorbic Acid, Beta-Glucan, Bisabolol, Butylene Glycol, Calcium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Cordyceps Militaris Mycelium Extract, Dimethicone, Dimethicone Crosspolymer, Erythritol, Ethylhexylglycerin, Glycerin, Glycine Soja (Soybean) Seed Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Hexyl Laurate, Homarine HCL, Iron Oxides, Lactobacillus Ferment, Melanin, PEG-10 Dimethicone, Pentylene Glycol, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethyl Methacrylate, Potassium Sorbate, Retinyl Palmitate, Scutellaria Baicalensis Root Extract, Silica, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Citrate, Squalane, Stearic Acid, Tocopheryl Acetate, Tribehenin.
Outer Package Label
ZO® Skin Health
by ZEIN OBAGI MD
NDC 42851-064-04
BROAD-SPECTRUM
SUNSCREEN SPF 50
For sensitized skin
ZOX 12®
Lightweight, non-irritating mineral sunscreen for the most sensitive skin types and post-procedure skin. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin shields skin from aging effects of high-energy visible (HEV) light. Oxybenzone free.
ZOX 12®
Engineered with our exclusive 12-hour, time-release ZOX12® complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays.
Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials
zoskinhealth.com
INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH BROAD-SPECTRUM SUNSCREEN SPF 50
titanium dioxide, zinc oxide cream |
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Labeler - ZO Skin Health, Inc. (826468527) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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LIFETECH RESOURCES LLC | 622559110 | manufacture(42851-064) |