Whole Body Organic Sunscreen

Manufacturer
ALTEYA ORGANICS OOD
Effective date
2021-04-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:47:22

Label at a glance#

ProductWhole Body Organic Sunscreen
Active ingredientZINC OXIDE
Label structure10 sections

Storage and handling

​Other information: • ​ Store at temperatures between 70-90 o ​F/21-32 ​o ​C. Higher or lower temperatures may cause the product to separate or thicken.  •  ​May stain some fabrics.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Uncoated Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Use: • ​Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the chance 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 occurs. ​

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 right away.

DOSAGE & ADMINISTRATION SECTION

​Directions: •​ Apply generously (2mg /cm​2​ of skin) 15 minutes before sun exposure. • ​Reapply after 40 minutes of swimming or sweating, immediately after towel drying, atleast every 2 hours. ​• ​For Children under 6 months: ask a doctor.​ •​ ​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 15 or higher and other sun protection measures including: ​•​ limit time in the sun, especially from 10 a.m. - 2 p.m. ​•​ wear long- sleeve shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT SECTION

Inactive ​Ingredients: Simmondsia Chinensis (Jojoba) Seed Oil​*​, Helianthus Annuus (Sunflower) Seed Oil​*, Calendula Officinalis (Calendula) Flower Oil​*​, Cera Alba (Beeswax)​*​​,Copernicia Cerifera (Carnauba) Wax​*​, Butyrospermum Parkii (Shea Butter)​*​, Carthamus Tinctorius Seed Oil​ / Safflower Acid, Cocos Nucifera (Coconut) Oil​*​, Isoamyl Laurate​, Caprylic / Capric Triglycerides, Macadamia Integrifolia (Macadamia) Oil*​, Persea Gratissima (Avocado) Oil​*​, Theobroma Cacao (Cocoa) Butter​*​,  Rosa Damascena (Rose) Flower Extract, Calendula Officinalis (Flower) Extract​*​, Hippophae Rhamnoides (Seabuckthorn) Fruit Extract​*​, Oenothera Biennis (Evening Primrose) Oil​*​, Rosa Canina (Rosehip) Seed Oil​*​, Iron Oxides (CI 77492, CI 77491, CI 77499), Tocopherol (Vitamin E), Pelargonium Graveolens (Geranium) Oil​*​, Lavandula Angustifolia (Lavender) Oil​*​, Cymbopogon Martini (Palmarosa) Oil​*​, Linalool​**​, Geraniol​**​, Citronellol​**​, Eugenol​**​

​*​ Certified Organic Ingredients        ** ​Naturally occurring in essential oils

STORAGE AND HANDLING SECTION

​Other information: •​ Store at temperatures between 70-90o​F/21-32​o​C. Higher or lower temperatures may cause the product to separate or thicken. • ​May stain some fabrics.

SPL UNCLASSIFIED SECTION

95% Organic Natural Ingredients

Water Resistant 40 minutes

BROAD SPECTRUM SPF 30

UVA/UVB

SHEER TINT

Certified Organic

No harmful chemical ingredients

Not Tested on Animals

Manufactured by Alteya Organics LLC,

Yagoda 6167, Made in Bulgaria. www.AlteyaOrganics.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71330-10171330-101-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8af00ede-7110-4e1d-8a24-8c625d4fd97760b5b7c2-002e-4b0e-becd-3e69be648a852021-04-13WarningsExact identifier
spl id: 8af00ede-7110-4e1d-8a24-8c625d4fd977
spl set id: 60b5b7c2-002e-4b0e-becd-3e69be648a85

Reported adverse events (FAERS/openFDA)#

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