ORGANIC ROSE 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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Organic Rose Face Sunscreen

Drug Facts

Active Ingredients:

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 (2 mg/cm2 of skin) 15 minutes before sun exposure. • Reapply at least 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. - 2p.m. • wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients: Distilled Thermal Water, Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Glycerin*, Cucurbita Pepo (Pumpkin) Seed Oil*, Butyrospermum Parkii (Shea Butter)*, Simmondsia Chinensis (Jojoba) Oil*, Copernicia Cerifera (Carnauba Wax) *, Macadamia Integrifolia (Macadamia) Oil*, Caprylic/Capric Triglycerides, Polyglyceryl-6 Stearate (and) Polyglyceryl-6 Behenate , Isoamyl Laurate, Cera Alba (Beeswax)*, Lecithin*, Glyceryl Caprylate, Glyceryl Undecylenate, Cyamopsis Tetragonoloba (Guar) Gum*, Aloe Barbadensis (Aloe) Leaf Juice*, Persea Gratissima (Avocado) Oil*, Rosa Damascena (Rose) Flower Extract, 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.

AGE DEFENSE

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

RoseFace1

ORGANIC ROSE FACE SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71330-103
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
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
SHEA BUTTER (UNII: K49155WL9Y)  
JOJOBA OIL (UNII: 724GKU717M)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MACADAMIA OIL (UNII: 515610SU8C)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
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)  
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:71330-103-501 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(71330-103)

Revised: 4/2021
 
ALTEYA ORGANICS OOD