Initial Drug Listing - Tallow Sunscreen

Initial Drug Listing - Tallow Sunscreen
SPL v1
SPL
SPL Set ID 363e38bf-b4b4-dcc4-e063-6294a90a5d2f
Route
TOPICAL
Published
Effective Date 2025-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (25 mg)
Inactive Ingredients
Taraxacum Officinale (dandelion) Root Silicon Dioxide Xanthan Gum Dimethicone 1000 Lecithin, Soybean Isononyl Isononanoate Water Olea Europaea (olive) Fruit Oil C12-15 Alkyl Benzoate Cetearyl Alcohol Calcium Disodium Edta Squalane Saururus Chinensis Whole Beef Tallow Beeswax Butyrospermum Parkii (shea) Butter Vitamin E Polyethylene Glycol Succinate Simmondsia Chinensis (jojoba) Seed Oil Leuconostoc/radish Root Ferment Filtrate Glyceryl Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-19

Description

Non-Nano Zinc Oxide 25%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Helps prevent sunburn
  • If used as directed with othersun 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 belore 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 sunincreases your risk of skin cancer and eariy skin aging. Todecrease this risk, regularly use a sunscreen wiih a BroadSpectrum SPF value ot 15 or higher and other sunprotection 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 ofage: Ask a doclor
Description

Non-Nano Zinc Oxide 25%

Section 50565-1

lf product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Ask a doctor if rash occurs.

Section 50567-7

Keep out of eyes. Rinse with water to remowe.

Section 50570-1

on damaged or broken skin

Section 51727-6

Water, Beef Tallow, Beeswax, Butyrospermum Parkii {Shea)Butter, Vitamin E, Simmondsia Chinensis (Jojoba) seed oll, OleaEuropaea (Olive) Fruit Oil, Lecithin,C12-15 Alkyl Benzoate, Silica,Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate,Cetearyl Alcohol, lsononyi lsononanoate, Disodium EDTA, RadishRoot Ferment Filtrate, Saururus Chinensis Leaf/root Extract,Taraxacum Offcinale (Dandelion) Leaf Extract

Section 51945-4

Section 53413-1

servicegvigority.com

Section 55105-1

Sunscreen

Section 55106-9

Non-Nano Zinc Oxide 25%

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 othersun 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 belore 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 sunincreases your risk of skin cancer and eariy skin aging. Todecrease this risk, regularly use a sunscreen wiih a BroadSpectrum SPF value ot 15 or higher and other sunprotection 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 ofage: Ask a doclor
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

lf product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Ask a doctor if rash occurs.

Section 50567-7 (50567-7)

Keep out of eyes. Rinse with water to remowe.

Section 50570-1 (50570-1)

on damaged or broken skin

Section 51727-6 (51727-6)

Water, Beef Tallow, Beeswax, Butyrospermum Parkii {Shea)Butter, Vitamin E, Simmondsia Chinensis (Jojoba) seed oll, OleaEuropaea (Olive) Fruit Oil, Lecithin,C12-15 Alkyl Benzoate, Silica,Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate,Cetearyl Alcohol, lsononyi lsononanoate, Disodium EDTA, RadishRoot Ferment Filtrate, Saururus Chinensis Leaf/root Extract,Taraxacum Offcinale (Dandelion) Leaf Extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

servicegvigority.com

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Non-Nano Zinc Oxide 25%

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)