BOTNIA GENTLE SUN SPF 30- zinc oxide cream

Botnia Gentle Sun SPF 30 by

Drug Labeling and Warnings

Botnia Gentle Sun SPF 30 by is a Otc medication manufactured, distributed, or labeled by Botnia, Inc, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 18.00 %

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection
• 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.

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 or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

Directions.

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.

Other Information.

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

Inactive Ingredients

Astaxanthin, Calendula Officinalis (Calendula) Water, Caprylyl Glycol, Cetearyl Olivate, Cetyl Palmitate, Hippophae Rhamnoides Fruit Oil, Lactobacillus Ferment, Pelargonium Asperum (Rose Geranium) Water, Pelargonium Graveolens Flower Oil, Potassium Cetyl Phosphate, Rosa spp. Flower Water, Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Palmitate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water (Aqua), Xanthan Gum

Package Labeling:

INGREDIENTS AND APPEARANCE

BOTNIA GENTLE SUN SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87461-904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	180 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASTAXANTHIN (UNII: 8XPW32PR7I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
RASPBERRY SEED OIL (UNII: 9S8867952A)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SORBITAN PALMITATE (UNII: 77K6Z421KU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87461-904-00	1 in 1 BOX	01/19/2026
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/19/2026

Labeler - Botnia, Inc (036562518)

Registrant - Pure Source, LLC (080354456)