SPL v3
SPL
SPL Set ID 4bf1ca6b-5d87-40ee-97f4-89f1bfadcecb
Route
TOPICAL
Published
Effective Date 2025-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (14.6 g)
Inactive Ingredients
Triethoxycaprylylsilane Water Cocoyl Caprylocaprate Isoamyl Laurate Glycerin Polyglyceryl-6 Stearate Jojoba Oil Propanediol Shea Butter Xanthan Gum Phenoxyethanol Green Tea Leaf Cetyl Alcohol Silicon Dioxide Polyhydroxystearic Acid (2300 Mw) Pongamia Pinnata Seed Sphingofungin C Aloe Vera Leaf Juice Soybean Lecithin Betasizofiran Pullulan Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-19

Description

Zinc Oxide   14.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide   14.6%

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.
Section 42229-5

Questions or Comments?

Call 1 (800) 931-9254

Section 50565-1

Warnings

For external use only.

Stop use and ask a doctorif rash occurs.

Do not useon damaged or broken skin.

When using this productKeep out of eyes.Rinse with water to remove.

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

Directions

Apply liberally 15 minutes before sun exposure

• Reapply:

• After 80 minutes of swimming or sweating

• Immediately after towel drying

• at least every 2 hours.

Children under 6 months: 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 Broad Spectrum of 15 or nigher and other sun protection measures, including:

• limit time in the sun, espec1ally from 10 a.m.- 2 p.m.

• wear long sleeve shirts, pants, hats & sunglasses

Product Label

Other Information
  • Protect this product from heat and direct sun.
  • May stain or damage some fabrics or surfaces. 
Inactive Ingredients

Triethoxycaprylylsilane, Water, Coco-Caprylate/Caprate, Isoamyl laurate, Glycerine, Polyglyceryl -6 Stearate, Jojoba Oil, Propanadiol, Shea Butter, Xanthum Gum, Phenoxyethanol, Green Tea Leaf Extract, Cetyl Alcohol, Silica, Polyhydroxystearic Acid, Pongomia Pinnata Seed Extract, Sphingomonas Ferment Extract, Aloe Barbadensis Leaf Extract, Lecithin, Sclerotium Gum, Pullulan, Ethylhexylglycerin

Active Ingredients                    

Zinc Oxide   14.6%


Structured Label Content

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.
Section 42229-5 (42229-5)

Questions or Comments?

Call 1 (800) 931-9254

Section 50565-1 (50565-1)

Purpose

Sunscreen

Warnings

For external use only.

Stop use and ask a doctorif rash occurs.

Do not useon damaged or broken skin.

When using this productKeep out of eyes.Rinse with water to remove.

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

Directions

Apply liberally 15 minutes before sun exposure

• Reapply:

• After 80 minutes of swimming or sweating

• Immediately after towel drying

• at least every 2 hours.

Children under 6 months: 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 Broad Spectrum of 15 or nigher and other sun protection measures, including:

• limit time in the sun, espec1ally from 10 a.m.- 2 p.m.

• wear long sleeve shirts, pants, hats & sunglasses

Product Label (Product label)

Other Information
  • Protect this product from heat and direct sun.
  • May stain or damage some fabrics or surfaces. 
Inactive Ingredients

Triethoxycaprylylsilane, Water, Coco-Caprylate/Caprate, Isoamyl laurate, Glycerine, Polyglyceryl -6 Stearate, Jojoba Oil, Propanadiol, Shea Butter, Xanthum Gum, Phenoxyethanol, Green Tea Leaf Extract, Cetyl Alcohol, Silica, Polyhydroxystearic Acid, Pongomia Pinnata Seed Extract, Sphingomonas Ferment Extract, Aloe Barbadensis Leaf Extract, Lecithin, Sclerotium Gum, Pullulan, Ethylhexylglycerin

Active Ingredients                    

Zinc Oxide   14.6%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)