Zo® Skin Health Sheer Fluid Broad-spectrum Sunscreen Spf 50

Zo® Skin Health Sheer Fluid Broad-spectrum Sunscreen Spf 50
SPL v3
SPL
SPL Set ID f218c158-19aa-ab90-e053-2a95a90aaef3
Route
TOPICAL
Published
Effective Date 2023-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.225 g)
Inactive Ingredients
Ethyl Ferulate Sodium Chloride Sodium Citrate Melanin Synthetic (tyrosine, Peroxide) Pentylene Glycol Vitamin A Palmitate Tocopherol Silicon Dioxide Glycerin Argan Oil Alpha-tocopherol Acetate Polysorbate 20 Triethoxycaprylylsilane Poly(methyl Methacrylate; 450000 Mw) Caprylyl Glycol Chlorphenesin Sunflower Oil Ascorbic Acid Water Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Levomenol Phenoxyethanol Rosemary Ethylhexylglycerin Dimethicone 1,2-hexanediol Ferric Oxide Red Alkyl (c12-15) Benzoate Butylene Glycol Dicaprylyl Carbonate Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

Active Ingredients Purpose Zinc Oxide 22.0% Sunscreen


Medication Information

Description

Active Ingredients Purpose Zinc Oxide 22.0% 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

Warnings

For external use only.

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.

Do Not Use
  • on damaged or broken skin.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients
Active Ingredients Purpose
Zinc Oxide 22.0% Sunscreen

Inactive Ingredients

Dimethicone, Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Butylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polysorbate 20, Dimethicone Crosspolymer, Ethyl Ferulate, Triethoxycaprylylsilane, Bisabolol, Phenoxyethanol, Polymethyl Methacrylate, Caprylyl Glycol, Chlorphenesin, Sodium Chloride, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Melanin, Pentylene Glycol, 1,2-Hexanediol, Ascorbic Acid, Retinyl Palmitate, Beta-Glucan, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ethylhexylglycerin, Iron Oxides.

Principal Display Panel

ZO® Skin Health

by Zein Obagi MD

NDC 42851-091-50

Sheer Fluid Broad-Spectrum Sunscreen SPF 50

ZOX12®

50 mL / 1.7 Fl. Oz.

Mineral fluid sunscreen with a natural, bare-faced finish for all skin types. Antioxidant-rich formula defends skin against environmental aggressors. Provides broad-spectrum protection against UVA/UVB. Natural melanin shields skin from aging effects of high-energy visible (HEV) light.

Oxybenzone free.

Shake well before dispensing.

ZOX12®

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 | 916700

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

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

Warnings

For external use only.

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.

Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients
Active Ingredients Purpose
Zinc Oxide 22.0% Sunscreen

Inactive Ingredients

Dimethicone, Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Butylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polysorbate 20, Dimethicone Crosspolymer, Ethyl Ferulate, Triethoxycaprylylsilane, Bisabolol, Phenoxyethanol, Polymethyl Methacrylate, Caprylyl Glycol, Chlorphenesin, Sodium Chloride, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Melanin, Pentylene Glycol, 1,2-Hexanediol, Ascorbic Acid, Retinyl Palmitate, Beta-Glucan, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ethylhexylglycerin, Iron Oxides.

Principal Display Panel

ZO® Skin Health

by Zein Obagi MD

NDC 42851-091-50

Sheer Fluid Broad-Spectrum Sunscreen SPF 50

ZOX12®

50 mL / 1.7 Fl. Oz.

Mineral fluid sunscreen with a natural, bare-faced finish for all skin types. Antioxidant-rich formula defends skin against environmental aggressors. Provides broad-spectrum protection against UVA/UVB. Natural melanin shields skin from aging effects of high-energy visible (HEV) light.

Oxybenzone free.

Shake well before dispensing.

ZOX12®

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 | 916700

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data


Raw Label Data

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