Sunscreen + Powder Broad-spectrum Spf 45 (deep)

Sunscreen + Powder Broad-spectrum Spf 45 (deep)
SPL v5
SPL
SPL Set ID beb0b43b-a90d-05ae-e053-2995a90a1d8e
Route
TOPICAL
Published
Effective Date 2021-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Active Ingredients Purpose Zinc Oxide 25.0% Sunscreen


Medication Information

Indications and Usage

Purpose   Sunscreen

Description

Active Ingredients 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 zoskinhealth.com | 972300

Section 43683-2

Updated categorization of Directions to Indications & Usage Section (previously designated the Dosage & Administration Section).

Designated the Drug Facts parent with classification of Dosage & Administration. The preceding transmission was accepted without a category.

Section 44425-7
  • Protect the product in this container from excessive heat and direct sun.
Section 53413-1
  • You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618
Warnings

For external use only.

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.
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.
Active Ingredients
Active Ingredients Purpose
Zinc Oxide 25.0% Sunscreen

Inactive Ingredients

HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis

(Jojoba) Seed Oil, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.

Principal Display Panel

ZO® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-069-27

SUNSCREEN + POWDER BROAD-SPECTRUM SPF 45

ZOX12®

DEEP

Net Wt. 2.7 g / 0.09 Oz.

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
Indications and Usage (34067-9)

Purpose   Sunscreen

Section 42229-5 (42229-5)

Dist. by ZO Skin Health, Inc. Irvine, CA 92618 Made in USA with US & imported materials zoskinhealth.com | 972300

Section 43683-2 (43683-2)

Updated categorization of Directions to Indications & Usage Section (previously designated the Dosage & Administration Section).

Designated the Drug Facts parent with classification of Dosage & Administration. The preceding transmission was accepted without a category.

Section 44425-7 (44425-7)
  • Protect the product in this container from excessive heat and direct sun.
Section 53413-1 (53413-1)
  • You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618
Warnings

For external use only.

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.
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.
Active Ingredients
Active Ingredients Purpose
Zinc Oxide 25.0% Sunscreen

Inactive Ingredients

HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis

(Jojoba) Seed Oil, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.

Principal Display Panel

ZO® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-069-27

SUNSCREEN + POWDER BROAD-SPECTRUM SPF 45

ZOX12®

DEEP

Net Wt. 2.7 g / 0.09 Oz.

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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