Zo ® Skin Health Sunscreen + Powder Broad-spectrum Spf 45 (light)

Zo ® Skin Health Sunscreen + Powder Broad-spectrum Spf 45 (light)
SPL v9
SPL
SPL Set ID be25489e-c3bf-77c5-e053-2a95a90a30de
Route
TOPICAL
Published
Effective Date 2023-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.675 mg)
Inactive Ingredients
Tribasic Calcium Phosphate Poly(methyl Methacrylate; 450000 Mw) Copper Triethoxycaprylylsilane Water Mica Ethylhexylglycerin Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Jojoba Butter Jojoba Oil Levomenol Ethyl Ferulate Ascorbic Acid Ferric Oxide Red Pentylene Glycol .alpha.-tocopherol Acetate Vitamin A Palmitate Phenoxyethanol Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-09

Description

Active Ingredient Purpose Zinc Oxide 25.0% Sunscreen


Medication Information

Dosage and Administration

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.

■ Sun alert: Limiting sun exposure, wearing protective clothing,

and using sunscreens may reduce the risks of skin aging, skin cancer,

and other harmful effects of the sun.

■ Protect the product in this container from excessive

heat and direct sun.

■ You may report a serious adverse reaction

to: 9685 Research Dr., Irvine, CA 92618

Description

Active Ingredient Purpose Zinc Oxide 25.0% 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
Section 42229-5

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA with US & imported materials

Section 50569-3
  • ​ If swallowed, get medical help or contact a Poison Control Center right away.
Section 55105-1

Purpose  Sunscreen

Warnings

For external use only.

Do Not Use
  • on damaged or broken skin.
Other Information
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Protect the product in this container from excessive heat and direct sun.
  • You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618
Active Ingredients

Active Ingredient Purpose
Zinc Oxide 25.0% Sunscreen

Inactive Ingredients

Mica, Hydroxyapatite, Polymethyl Methacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Triethoxycaprylylsilane, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol, Iron Oxides.

Principal Display Panel

ZO® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-049-27

SUNSCREEN + POWDR BROAD-SPECTRUM SPF 45

ZOX12™

LIGHT

Net Wt. 2.7 g / 0.09 Oz.

res

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs.

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
Dosage and Administration (34068-7)

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.

■ Sun alert: Limiting sun exposure, wearing protective clothing,

and using sunscreens may reduce the risks of skin aging, skin cancer,

and other harmful effects of the sun.

■ Protect the product in this container from excessive

heat and direct sun.

■ You may report a serious adverse reaction

to: 9685 Research Dr., Irvine, CA 92618

Section 42229-5 (42229-5)

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA with US & imported materials

Section 50569-3 (50569-3)
  • ​ If swallowed, get medical help or contact a Poison Control Center right away.
Section 55105-1 (55105-1)

Purpose  Sunscreen

Warnings

For external use only.

Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Protect the product in this container from excessive heat and direct sun.
  • You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618
Active Ingredients

Active Ingredient Purpose
Zinc Oxide 25.0% Sunscreen

Inactive Ingredients

Mica, Hydroxyapatite, Polymethyl Methacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Triethoxycaprylylsilane, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol, Iron Oxides.

Principal Display Panel

ZO® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-049-27

SUNSCREEN + POWDR BROAD-SPECTRUM SPF 45

ZOX12™

LIGHT

Net Wt. 2.7 g / 0.09 Oz.

res

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.

Advanced Ingredient Data


Raw Label Data

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