BIO DAMASCENA ROSE OTTO FACE 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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 BIO DAMASCENA ROSE OTTO FACE SUNSCREEN

Drug Facts

Active Ingredient:

Non-Nano Uncoated Zinc Oxide 18%

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 atleast every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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: Distilled Thermal Water, Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Glycerin*, Butyrospermum Parkii (Shea Butter)*, Simmondsia Chinensis (Jojoba) Oil*, Cucurbita Pepo (Pumpkin) Seed Oil*, Copernicia Cerifera (Carnauba Wax)*, Polyglyceryl-6 Stearate (and) Polyglyceryl-6 Behenate, Caprylic / Capric Triglycerides, Cera Alba (Beeswax)*, Lecithin*,  Isoamyl Laurate, Macadamia Integrifolia (Macadamia) Oil*, Glyceryl Caprylate, Glyceryl Undecylenate, Cyamopsis Tetragonoloba (Guar) Gum*, Aloe Barbadensis (Aloe) Leaf Juice*, Persea Gratissima (Avocado) Oil*, Rosa Damascena (Rose) Flower Extract, Rosa Damascena (Rose) Flower Oil*, Pistacia Lentiscus (Mastic) Gum, Oenothera Biennis (Evening Primrose) Oil*, Rosa Canina (Rosehip) Seed Oil*, Euterpe Oleracea (Acai) Fruit Oil*, Iron Oxides (CI 77492, CI 77491, CI 77499), Tocopherol (Vitamin E), Hippophae Rhamnoides (Seabuckthorn) Fruit Extract*, Calendula officinalis (Flower) Extract*, Lavandula Angustifolia (Lavender) Oil*, Cymbopogon Martini (Palmarosa) Oil*, Anthemis Nobilis (Roman Chamomile) Flower Oil*, Linalool**, Geraniol**, Citronellol**, Eugenol**

* Certified Organic Ingredients

** Naturally occurring in essential oils

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.

BROAD SPECTRUM SPF 25

Sheer Tint

Ageless UVA/UVB Care

CERTIFIED ORGANIC

No harmful chemical ingredients

Not Tested on Animals

Manufactured by Alteya Organics LLC.

Yagoda 6167, Made in Bulgaria

www.AlteyaOrganics.com

Packaging

RoseOtto1

BIO DAMASCENA ROSE OTTO FACE SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71330-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
JOJOBA OIL (UNII: 724GKU717M)  
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
MACADAMIA OIL (UNII: 515610SU8C)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
GUAR GUM (UNII: E89I1637KE)  
ALOE (UNII: V5VD430YW9)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
ROSA CANINA SEED (UNII: 4503R1M9UT)  
ACAI OIL (UNII: Z0W6766A2W)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TOCOPHEROL (UNII: R0ZB2556P8)  
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PALMAROSA OIL (UNII: 0J3G3O53ST)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71330-104-501 in 1 BOX04/01/201704/30/2021
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
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(71330-104)

Revised: 4/2021
 
ALTEYA ORGANICS OOD