Initial Drug Listing - Tallow Sunscreen Spf30 Jar

Initial Drug Listing - Tallow Sunscreen Spf30 Jar
SPL v1
SPL
SPL Set ID 3b4f5941-15ae-a760-e063-6394a90a2abe
Route
TOPICAL
Published
Effective Date 2025-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (19 g)
Inactive Ingredients
Cocos Nucifera (coconut) Oil Beeswax Butyrospermum Parkii (shea) Butter Daucus Carota Sativa (carrot) Seed Oil Beef Tallow Rubus Idaeus (raspberry) Seed Oil Simmondsia Chinensis (jojoba) Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-26
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 51727-6

Beef Tallow, Beeswax, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) seed oil, Cocos Nucifera (Coconut) Oil, Rubus Idaeus (Red Raspberry) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil

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 51727-6 (51727-6)

Beef Tallow, Beeswax, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) seed oil, Cocos Nucifera (Coconut) Oil, Rubus Idaeus (Red Raspberry) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil

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: 2026-02-15T12:06:51.579888 · Updated: 2026-03-14T23:09:51.959406