KIDS AND BABY ORGANIC SUNSCREEN- zinc oxide lotion

KIDS AND BABY ORGANIC SUNSCREEN by

Drug Labeling and Warnings

KIDS AND BABY ORGANIC SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ALTEYA ORGANICS OOD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

Non-Nano Uncoated Zinc Oxide 20%

Purpose

Sunscreen

INDICATIONS & USAGE

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

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.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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

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

INGREDIENTS AND APPEARANCE

KIDS AND BABY ORGANIC SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71330-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
SAFFLOWER ACID (UNII: Y788KS82OV)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MACADAMIA OIL (UNII: 515610SU8C)
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)
COCOA BUTTER (UNII: 512OYT1CRR)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71330-102-90	90 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2017

Labeler - ALTEYA ORGANICS OOD (503572407)

Establishment
Name	Address	ID/FEI	Business Operations
ALTEYA ORGANICS OOD		503572407	manufacture(71330-102)