WHOLE BODY ORGANIC SUNSCREEN- zinc oxide lotion

Whole Body Organic Sunscreen by

Drug Labeling and Warnings

Whole Body 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​: ​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 /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

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

​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

INGREDIENTS AND APPEARANCE

WHOLE BODY ORGANIC SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71330-101
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)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
SAFFLOWER OIL (UNII: 65UEH262IS)
SAFFLOWER ACID (UNII: Y788KS82OV)
COCONUT OIL (UNII: Q9L0O73W7L)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MACADAMIA OIL (UNII: 515610SU8C)
AVOCADO OIL (UNII: 6VNO72PFC1)
COCOA BUTTER (UNII: 512OYT1CRR)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
ROSA CANINA SEED (UNII: 4503R1M9UT)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TOCOPHEROL (UNII: R0ZB2556P8)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PALMAROSA OIL (UNII: 0J3G3O53ST)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71330-101-90	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(71330-101)