FDA.reportPublic FDA data

KIDS AND BABY 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#

ProductKIDS AND BABY 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 /cm2 of skin) 15 minutes before sun exposure. • Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least 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)*, Butyrospermum Parkii (Shea Butter)*, Copernicia Cerifera (Carnauba) Wax*, Carthamus Tinctorius Seed Oil / Safflower Acid, Isoamyl Laurate, Caprylic/Capric Triglycerides, Macadamia Integrifolia (Macadamia) Oil*, Cocos Nucifera (Coconut) Oil*, Persea Gratissima (Avocado) Oil*, Theobroma Cacao (Cocoa) Butter*, Lavandula Angustifolia (Lavender) Oil*, Anthemis Nobilis (Roman Chamomile) Flower Oil*, Calendula Officinalis (Flower) Extract*, Hippophae Rhamnoides (Seabuckthorn) Fruit Extract*, Iron Oxides (CI 77492, CI 77491, CI 77499), Tocopherol (Vitamin E).

* Certified Organic Ingredients

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

95% Organic Natural Ingredients

Water Resistant 40 minutes

BROAD SPECTRUM SPF 30

UVA/UVB

SHEER TINT

Not Tested on Animals

Certified Organic

No harmful chemical ingredients

Manufactured by Alteya Organics LLC

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71330-10271330-102-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
JOJOBA OIL724GKU717MIACT
SUNFLOWER OIL3W1JG795YIIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
CARNAUBA WAXR12CBM0EIZIACT
SAFFLOWER OIL65UEH262ISIACT
SAFFLOWER ACIDY788KS82OVIACT
ISOAMYL LAURATEM1SLX00M3MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MACADAMIA OIL515610SU8CIACT
COCONUT OILQ9L0O73W7LIACT
AVOCADO OIL6VNO72PFC1IACT
COCOA BUTTER512OYT1CRRIACT
LAVENDER OILZBP1YXW0H8IACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
TOCOPHEROLR0ZB2556P8IACT

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
0fa60817-7cdb-4aec-bb2c-9ed76d17e07a6994e9e2-4157-4686-aedd-7b75bcf2cb752021-04-13WarningsExact identifier
spl id: 0fa60817-7cdb-4aec-bb2c-9ed76d17e07a
spl set id: 6994e9e2-4157-4686-aedd-7b75bcf2cb75

Reported adverse events (FAERS/openFDA)#

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