BIO DAMASCENA ROSE OTTO FACE 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 22:47:23

Label at a glance#

ProductBIO DAMASCENA ROSE OTTO FACE 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 18%

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 /cm2 of skin) 15 minutes before sun exposure. • Reapply atleast every 2 hours. Use a water-resistant sunscreen if swimming or sweating. • 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: Distilled Thermal Water, Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Glycerin*, Butyrospermum Parkii (Shea Butter)*, Simmondsia Chinensis (Jojoba) Oil*, Cucurbita Pepo (Pumpkin) Seed Oil*, Copernicia Cerifera (Carnauba Wax)*, Polyglyceryl-6 Stearate (and) Polyglyceryl-6 Behenate, Caprylic / Capric Triglycerides, Cera Alba (Beeswax)*, Lecithin*,  Isoamyl Laurate, Macadamia Integrifolia (Macadamia) Oil*, Glyceryl Caprylate, Glyceryl Undecylenate, Cyamopsis Tetragonoloba (Guar) Gum*, Aloe Barbadensis (Aloe) Leaf Juice*, Persea Gratissima (Avocado) Oil*, Rosa Damascena (Rose) Flower Extract, Rosa Damascena (Rose) Flower Oil*, Pistacia Lentiscus (Mastic) Gum, Oenothera Biennis (Evening Primrose) Oil*, Rosa Canina (Rosehip) Seed Oil*, Euterpe Oleracea (Acai) Fruit Oil*, Iron Oxides (CI 77492, CI 77491, CI 77499), Tocopherol (Vitamin E), Hippophae Rhamnoides (Seabuckthorn) Fruit Extract*, Calendula officinalis (Flower) Extract*, Lavandula Angustifolia (Lavender) Oil*, Cymbopogon Martini (Palmarosa) Oil*, Anthemis Nobilis (Roman Chamomile) Flower Oil*, Linalool**, Geraniol**, Citronellol**, Eugenol**

* Certified Organic Ingredients

** Naturally occurring in essential oils

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

BROAD SPECTRUM SPF 25

Sheer Tint

Ageless UVA/UVB Care

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

RoseOtto1RoseOtto1

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71330-10471330-104-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML · Source PDF

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
238129fd-5822-4ab0-b919-7099c693eed8b590ac3d-b53d-41f8-9f1a-0a35a4f312be2021-04-13WarningsExact identifier
spl id: 238129fd-5822-4ab0-b919-7099c693eed8
spl set id: b590ac3d-b53d-41f8-9f1a-0a35a4f312be

Reported adverse events (FAERS/openFDA)#

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