Sunscreen In The Raw

Manufacturer
Biomin LLC
Effective date
2024-02-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:54

Label at a glance#

ProductSunscreen In The Raw
Active ingredientZINC OXIDE
Label structure9 sections

Storage and handling

Other information: Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (25%)

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Uses: •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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: 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 of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10am-2pm. • Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6 months: consult a physician.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Argania Spinosa Kernel Oil, Rosa Canina Fruit Oil, Tocopheryl Acetate.

STORAGE AND HANDLING SECTION

Other information: Protect this product from excessive heat and direct sun.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SunscreenSunscreen

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82177-003-00Sunscreen In The Raw86 g in 1 TUBELOTION861

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82177-003SUNSCREEN IN THE RAW (ZINC OXIDE) LOTION [BIOMIN LLC]11 package rows20240224_11d6315b-8936-7346-e063-6294a90a31b0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82177-00382177-003-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
11d6315b-8937-7346-e063-6294a90a31b011d6315b-8936-7346-e063-6294a90a31b02024-02-20WarningsExact identifier
spl id: 11d6315b-8937-7346-e063-6294a90a31b0
spl set id: 11d6315b-8936-7346-e063-6294a90a31b0

Reported adverse events (FAERS/openFDA)#

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