Initial Drug Listing - Vigority Tallow Sunscreen Spf30

Initial Drug Listing - Vigority Tallow Sunscreen Spf30
SPL v1
SPL
SPL Set ID 3b410ed7-c629-e39c-e063-6294a90a12f6
Route
TOPICAL
Published
Effective Date 2025-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (19 g)
Inactive Ingredients
Water Xanthan Gum Lecithin, Soybean Isononyl Isononanoate Beef Tallow Butyrospermum Parkii (shea) Butter Saururus Chinensis Whole Beeswax Leuconostoc/radish Root Ferment Filtrate C12-15 Alkyl Benzoate Silica Glyceryl Stearate Cetearyl Alcohol Taraxacum Officinale Leaf Squalane Dimethicone Simmondsia Chinensis (jojoba) Seed Oil Tocopherol Olea Europaea (olive) Fruit Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-25
Description

Non-Nano Zinc Oxide 19%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • 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

Dosage and Administration
  • apply liberally 15 minutes before sun exposure
  • reapply: - after 80 minutes of swimming or sweating - immediately after towel drying - 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 a.m. - 2 p.m. - wear long-sleeved shirts, pants, hats and sunglasses - children under 6 months of age: Ask a doctor

Description

Non-Nano Zinc Oxide 19%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Water, Beef Tallow, Beeswax, Butyrospermum Parkii (Shea) Butter, Vitamin E, Simmondsia Chinensis (Jojoba) seed oil, Olea Europaea (Olive) Fruit Oil, Lecithin, C12-15 Alkyl Benzoate, Silica, Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate, Cetearyl Alcohol, Isononyl Isononanoate, Radish Root Ferment Filtrate, Saururus Chinensis Leaf/root Extract, Taraxacum Officinale (Dandelion) Leaf Extract

Section 51945-4

Section 53413-1

[email protected]

Section 55105-1

Sunscreen

Section 55106-9

Non-Nano Zinc Oxide 19%

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)
  • 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

Dosage and Administration (34068-7)
  • apply liberally 15 minutes before sun exposure
  • reapply: - after 80 minutes of swimming or sweating - immediately after towel drying - 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 a.m. - 2 p.m. - wear long-sleeved shirts, pants, hats and sunglasses - children under 6 months of age: Ask a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Water, Beef Tallow, Beeswax, Butyrospermum Parkii (Shea) Butter, Vitamin E, Simmondsia Chinensis (Jojoba) seed oil, Olea Europaea (Olive) Fruit Oil, Lecithin, C12-15 Alkyl Benzoate, Silica, Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate, Cetearyl Alcohol, Isononyl Isononanoate, Radish Root Ferment Filtrate, Saururus Chinensis Leaf/root Extract, Taraxacum Officinale (Dandelion) Leaf Extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

[email protected]

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Non-Nano Zinc Oxide 19%

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:51.450655 · Updated: 2026-03-14T23:09:51.959406