WHOLE BODY 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.

----------

WHOLE BODY 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 /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 ​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

​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.

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

image description

WHOLE BODY ORGANIC SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71330-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71330-101-9090 mL in 1 TUBE; Type 0: Not a Combination Product04/01/201704/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/201704/30/2021
Labeler - ALTEYA ORGANICS OOD (503572407)
Establishment
NameAddressID/FEIBusiness Operations
ALTEYA ORGANICS OOD503572407manufacture(71330-101)

Revised: 4/2021
 
ALTEYA ORGANICS OOD