ORGANIC ROSE LIP BALM SUNSCREEN

Drug Labeling and Warnings

Drug Details [pdf]

ORGANIC ROSE LIP BALM SUNSCREEN- zinc oxide lipstick 
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 LIP BALM SUNSCREEN

Drug Facts

Active Ingredients

Non-Nano Uncoated Zinc Oxide 10.00%

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. Discontinue use and ask a doctor if rash occurs  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 old: 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am-2 pm; wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients: Simmondsia Chinensis (Jojoba) Oil*, Helianthus Annuus (Sunflower) Oil*, Cera Alba (Beeswax)*, Theobroma Cacao (Cocoa) Butter*, Buty-rospermum Parkii (Shea Butter)*, Cucurbita Pepo (Pumpkin) Seed Oil*, Euphorbia Cerifera (candelilla) Wax, Olea Europaea (Olive) Fruit Oil*, Persea Gratissima (Avocado) Oil*, Rosa Damascena Flower Extract, Copernicia Cerifera (Carnauba) Wax*, Hippophae Rhamnoides (Seabuckthorn) Fruit Extract*, Iron Îxides (CI 77492, CI 77491, CI 77499), Tocopherol (Vitamin E),

Linalool**, Geraniol**, Citronellol**, Eugenol**
* certified organic ingredients; ** naturally occurring in essential oils

Other information: Protect this product in this container from excessive heat and direct sun. Store at temperatures between 70-90ºF/21-32°C. Higher or much lower temperatures may cause the product to separate or thicken.  May stain some fabrics

96% Organic Natural Ingredients 

UVA/UVB Hydration and Sun Protection

BROAD SPECTRUM SPF 15

CERTIFIED ORGANIC NO HARMFUL CHEMICAL INGREDIENTS

Not Tested on Animals

Manufactured by Alteya Organics Ltd

Village of Yagoda 6167, Bulgaria

www.AlteyaOrganics.com

Packaging

image description

ORGANIC ROSE LIP BALM SUNSCREEN 
zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71330-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL (UNII: 724GKU717M)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SHEA BUTTER (UNII: K49155WL9Y)  
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
CANDELILLA WAX (UNII: WL0328HX19)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71330-105-051 in 1 BOX04/01/201704/15/2019
15 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/201704/15/2019
Labeler - ALTEYA ORGANICS OOD (503572407)
Establishment
NameAddressID/FEIBusiness Operations
ALTEYA ORGANICS OOD503572407manufacture(71330-105)

Revised: 5/2019
 

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