FDA.reportPublic FDA data

Botnia Gentle Sun Cream SPF 30

Manufacturer
Botnia, Inc | Pure Source, LLC
Effective date
2026-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:48:39

Label at a glance#

ProductBotnia Gentle Sun SPF 30
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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.

Dosage and administration

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 me...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18.00 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • On damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions.

DOSAGE & ADMINISTRATION SECTION

  • 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.

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label2Outer Label2Inner Label2Inner Label2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87461-904-00Botnia Gentle Sun SPF 3050 mL in 1 TUBECREAM501
87461-904-00Botnia Gentle Sun SPF 301 in 1 BOXCREAM11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87461-90487461-904-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASTAXANTHIN8XPW32PR7IIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL PALMITATE5ZA2S6B08XIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
RASPBERRY SEED OIL9S8867952AIACT
JOJOBA OIL724GKU717MIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SORBITAN OLIVATEMDL271E3GRIACT
SORBITAN PALMITATE77K6Z421KUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GRAPE SEED OIL930MLC8XGGIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Botnia Gentle Sun SPF 30ZINC OXIDEBotnia, Inc005d0245-fe53-47e5-888b-683f58cd6d262026-03-03WarningsExact identifier
ndc (package): 87461-904-00
ndc (product): 87461-904
ndc11 (package): 87461090400
spl id: 4c1e721a-a8f5-db1b-e063-6294a90a0a26
spl set id: 005d0245-fe53-47e5-888b-683f58cd6d26

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.