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NDC 42851-0055-20 ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL Details
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by ZO Skin Health, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.
Product Information
| NDC | 42851-0055 |
|---|---|
| Product ID | 42851-055_dd09abaa-c8e1-5621-e053-2a95a90a6cbf |
| 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 Smart Tone Broad-Spectrum Sunscreen SPF 50 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Avobenzone, Homosalate, Octisalate, Octocrylene |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 30; 100; 50; 100 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL; mg/mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE |
| 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 42851-0055-20 (42851005520)
| NDC Package Code | 42851-055-20 |
|---|---|
| Billing NDC | 42851005520 |
| Package | 1 TUBE in 1 CARTON (42851-055-20) / 20 mL in 1 TUBE |
| Marketing Start Date | 2022-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cda67d41-d063-4936-a6b9-23376304eb42 Details
Drug Facts
Active Ingredients
| Active Ingredients | Purpose |
| Avobenzone 3% ............... | Sunscreen |
| Homosalate 10%............... | Sunscreen |
| Octisalate 5%................... | Sunscreen |
| Octocrylene 10% .............. | Sunscreen |
Uses
- Helps prevent sunburn
- Higher SPF gives more sunburn protection
- Provides high protection against 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
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.
- Use a water-resistant sunscreen if swimming or sweating.
- Reapply: 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
Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, PEG-100 Stearate, Butylene Glycol, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Petasites Japonicus Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Melanin, Pentylene Glycol, Boron Nitride, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Beta-Glucan, Ethylene Brassylate, Polymethyl
Methacrylate, Acrylates/Ammonium Methacrylate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Acrylates Crosspolymer-4, Panthenyl Triacetate, Glycerin, Aluminum Hydroxide, Simethicone, Ethyl Linoleate, Oleyl Alcohol,
Cetearyl Alcohol, PEG-8 Laurate, Steareth-2, Coco-Glucoside, Isostearic Acid, Sodium Hydroxide, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Fragrance, Titanium Dioxide, Iron Oxides.
Principal Display Panel
ZO® SKIN HEALTH
by ZEIN OBAGI MD
NDC 42851-055-45
Smart Tone Broad-Spectrum Sunscreen SPF 50
ZOX12 ®
Ultra-lightweight sunscreen with customizable color beads designed to blend into most skin tones. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin helps shield skin from the aging effects of high-energy visible (HEV) light. Oxybenzone free.
ZOX12 ®
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 | 973380
INGREDIENTS AND APPEARANCE
| ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion |
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| Labeler - ZO Skin Health, Inc. (826468527) |