SPL v1
SPL
SPL Set ID 41d75815-e281-bf88-e063-6294a90afeff
Route
TOPICAL
Published
Effective Date 2025-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (150 mg)
Inactive Ingredients
Caprylic/capric Triglyceride Lavandula Angustifolia (lavender) Oil Hydrolyzed Jojoba Esters Polygonum Aviculare Top Caprylhydroxamic Acid Bisabolol Glyceryl Stearate Glyceryl Caprate Borago Officinalis Whole Linalyl Acetate Water Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-6 Distearate Allantoin Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Diheptyl Succinate Rosa Damascena Flower Oil Propanediol Linalool Sodium Pca Tocopherol Glycerin Sorbitan Sesquioleate Sodium Stearoyl Glutamate Polyglyceryl-6 Polyricinoleate Butyloctyl Salicylate Hyaluronic Acid Squalane Glycine Soja (soybean) Oil Unsaponifiables Pongamia Pinnata Seed Citrus Aurantium Amara (bitter Orange) Peel Oil Betaine Starch, Tapioca Aloe Barbadensis Leaf Juice Calendula Officinalis Flower Jojoba Oil Xanthan Gum Tagetes Minuta Flower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-23

Description

Purpose Zinc Oxide 15% ..............................................Sunscreen

Purpose

Purpose Zinc Oxide 15%..............................................Sunscreen


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses

Helps prevent 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

Purpose

Purpose

Zinc Oxide 15%..............................................Sunscreen

Description

Purpose Zinc Oxide 15% ..............................................Sunscreen

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

keep outof eyes.

Rinse with water to remove

Section 50569-3

Stop use and ask a doctor if rash occurs

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Feruloyl Soy Glycerides, Polyglyceryl-6 Distearate, Glycerin, Betaine, Propanediol, Tapioca Starch, Glyceryl Stearate, Sorbitan Sesquioleate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Allantoin, Bisabolol, Hyaluronic Acid, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Pongamia Pinnata Seed Extract, Lavandula Angustifolia (Lavender) Oil, Glyceryl Caprylate, Dilheptyl Succinate, Polyhydroxystearic Acid, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Xanthan Gum, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium PCA, Tocopherol, Caprylhydroxamic Acid, Glycine Soja (Soybean) Oil, Citric Acid, Iron Oxides (Cl 77492), Citrus Aurantium Amara (Bitter Orange) Peel Oil, Rosa Damascena Flower Oil, Tagetes Minuta Flower Oil, Borago Officinalis (Common Borage), Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Polygonum Aviculare Extract, Linalool, Linalyl Acetate, Lavandula Oil / Extract

Section 51945-4

Section 53413-1

Questions or Commets? call toll free 646-979-3997

Section 60561-8

Protect the product in this container from excessive heat and direct sun

Directions

Directions

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

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

Children under 6 months of age: ask a doctor

Active Ingredients

Purpose

Zinc Oxide 15% ..............................................Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps prevent 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 and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

keep outof eyes.

Rinse with water to remove

Section 50569-3 (50569-3)

Stop use and ask a doctor if rash occurs

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Feruloyl Soy Glycerides, Polyglyceryl-6 Distearate, Glycerin, Betaine, Propanediol, Tapioca Starch, Glyceryl Stearate, Sorbitan Sesquioleate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Allantoin, Bisabolol, Hyaluronic Acid, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Pongamia Pinnata Seed Extract, Lavandula Angustifolia (Lavender) Oil, Glyceryl Caprylate, Dilheptyl Succinate, Polyhydroxystearic Acid, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Xanthan Gum, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium PCA, Tocopherol, Caprylhydroxamic Acid, Glycine Soja (Soybean) Oil, Citric Acid, Iron Oxides (Cl 77492), Citrus Aurantium Amara (Bitter Orange) Peel Oil, Rosa Damascena Flower Oil, Tagetes Minuta Flower Oil, Borago Officinalis (Common Borage), Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Polygonum Aviculare Extract, Linalool, Linalyl Acetate, Lavandula Oil / Extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Commets? call toll free 646-979-3997

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun

Purpose

Purpose

Zinc Oxide 15%..............................................Sunscreen

Directions

Directions

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

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

Children under 6 months of age: ask a doctor

Active Ingredients

Purpose

Zinc Oxide 15% ..............................................Sunscreen


Advanced Ingredient Data


Raw Label Data

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