Your browser does not support JavaScript! ALBA TERRATINT GARNET SPF 15 LIP BALM (ZINC OXIDE) STICK [AUTUMN HARP, INC.]
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ALBA TERRATINT GARNET SPF 15 LIP BALM (zinc oxide) stick
[Autumn Harp, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredient

Zinc Oxide 5.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by sun exposure.

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 doctor if skin rash occurs. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: ask a doctor. Skin Protection Measures: Spending time in sun increases risk of skin cancer and early skin aging. To decrease risk, use sunscreen with Broad Spectrum SPF 15 or higher, limit time in sun, especially 10am-2pm, and wear hats and sunglasses.

Inactive Ingredients

Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Caprylic/Capric Triglyceride, Beeswax, Manganese Violet (CI 77742), Oryza Sativa (Rice) Bran Wax, Iron Oxides (CI 77491), Mentha Piperita (Peppermint) Oil*, Olea Europaea (Olive) Fruit Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Stevia Rebaudiana (Stevia) Leaf/Stem Extract*, Polyhydroxystearic Acid, Polyglyceryl-3 Diisostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Limonene*, Linalool*, Iron Oxides (CI77499),  Mica (CI 77019), Titanium Dioxide (CI 77891). *Certified Organic Ingredient

Other Information

Protect this product from excessive heat and direct sun

Questions?

Call (888) 659-7730 or visit www.albabotanica.com

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ALBA TERRATINT GARNET SPF 15 LIP BALM 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51514-0304
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE5.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL 
SUNFLOWER OIL 
CANDELILLA WAX 
YELLOW WAX 
MEDIUM-CHAIN TRIGLYCERIDES 
MANGANESE VIOLET 
RICE BRAN 
FERRIC OXIDE RED 
PEPPERMINT OIL 
POLYHYDROXYSTEARIC ACID (2300 MW) 
TRIETHOXYCAPRYLYLSILANE 
ALPHA-TOCOPHEROL ACETATE 
MICA 
OLIVE OIL 
STEVIA REBAUDIUNA LEAF 
POLYGLYCERYL-3 DIISOSTEARATE 
TITANIUM DIOXIDE 
FERROSOFERRIC OXIDE 
LIMONENE, (+/-)- 
CALENDULA OFFICINALIS FLOWER 
ECHINACEA PURPUREA 
LINALOOL, (+/-)- 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0304-14.2 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2012
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0304)

Revised: 9/2013
 
Autumn Harp, Inc.

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