KIDS AND BABY ORGANIC SUNSCREEN- zinc oxide lotion
ALTEYA ORGANICS OOD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KIDS AND BABY ORGANIC SUNSCREEN

Drug Facts

Active Ingredient:

Non-Nano Uncoated Zinc Oxide 20%

Purpose

Sunscreen

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: 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. If product is swallowed, get medical help or contact a Poison Control Center right away.

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 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

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.

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

image description

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71330-102-90	90 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2017	04/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2017	04/30/2021

Labeler - ALTEYA ORGANICS OOD (503572407)

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

Revised: 4/2021

Document Id: 0fa60817-7cdb-4aec-bb2c-9ed76d17e07a

Set id: 6994e9e2-4157-4686-aedd-7b75bcf2cb75

Version: 5

Effective Time: 20210413

ALTEYA ORGANICS OOD