Prime Time Daily Protecting Primer Spf 30

Prime Time Daily Protecting Primer Spf 30
SPL v1
SPL
SPL Set ID f2619092-3e7f-5105-e053-2a95a90a3f5a
Route
TOPICAL
Published
Effective Date 2023-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10.49 g) Titanium Dioxide (3.13 g)
Inactive Ingredients
Medium-chain Triglycerides Tocopherol Ferric Oxide Red Isopropyl Titanium Triisostearate Coco-caprylate/caprate Undecane Polyglyceryl-6 Polyricinoleate Starch, Tapioca Tridecane Stearic Acid Water Glycerin Magnesium Sulfate Anhydrous 1,2-hexanediol Theobroma Cacao Whole Caprylhydroxamic Acid Lecithin, Sunflower Polyglyceryl-3 Pentaricinoleate Triethoxycaprylylsilane Glyceryl Isostearate Polyhydroxystearic Acid (2300 Mw) .alpha.-bisabolol, (+)- Ferric Oxide Yellow Polyglyceryl-2 Isostearate Butylene Glycol Isopropyl Myristate Isostearic Acid Biosaccharide Gum-4 Propylene Carbonate Hydrogenated Palm Kernel Oil Phenoxyethanol Disteardimonium Hectorite Propanediol Aluminum Oxide Isononyl Isononanoate Camellia Japonica Seed Oil .alpha.-tocopherol Stearalkonium Hectorite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-02

Description

Titanium Dioxide 3.1% Zinc Oxide 10.49%


Medication Information

Indications and Usage

Sunscreen

Sunscreen

Description

Titanium Dioxide 3.1% Zinc Oxide 10.49%

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 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Directions
  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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 am - 2 pm
  • wear long sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor
Questions?

Call toll free 1-888-795-4747

Other Information

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

Active Ingredients

Titanium Dioxide 3.1%

Zinc Oxide 10.49%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Undecane, Polyglyceryl-6 Polyricinoleate, Tapioca Starch, Glycerin, Tridecane, Magnesium Sulfate, Polyglyceryl-2 Isostearate, Tocopherol, Hydrogenated Vegetable Oil, Phenoxyethanol, Glyceryl Isostearate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propanediol, Bisabolol, Stearic Acid, Iron Oxide (CI 77492), Alumina, 1,2-Hexanediol, Isononyl Isononanoate, Camellia Japonica Seed Oil, Theobroma Cacao (Cocoa) Extract, Butylene Glycol, Isopropyl Myristate, Isostearic Acid, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Biosaccharide gum-4, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Propylene Carbonate.

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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.
Indications and Usage (34067-9)

Sunscreen

Sunscreen

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Directions
  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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 am - 2 pm
  • wear long sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor
Questions?

Call toll free 1-888-795-4747

Other Information

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

Active Ingredients

Titanium Dioxide 3.1%

Zinc Oxide 10.49%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Undecane, Polyglyceryl-6 Polyricinoleate, Tapioca Starch, Glycerin, Tridecane, Magnesium Sulfate, Polyglyceryl-2 Isostearate, Tocopherol, Hydrogenated Vegetable Oil, Phenoxyethanol, Glyceryl Isostearate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propanediol, Bisabolol, Stearic Acid, Iron Oxide (CI 77492), Alumina, 1,2-Hexanediol, Isononyl Isononanoate, Camellia Japonica Seed Oil, Theobroma Cacao (Cocoa) Extract, Butylene Glycol, Isopropyl Myristate, Isostearic Acid, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Biosaccharide gum-4, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Propylene Carbonate.

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