TINTED LIP BALM SPF30 WILD PEONY- spf30 lip balm stick

Tinted Lip Balm SPF30 Wild Peony by

Drug Labeling and Warnings

Tinted Lip Balm SPF30 Wild Peony by is a Otc medication manufactured, distributed, or labeled by Autumn Harp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 19.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions) decreases the risk 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.

Directions

• For sunscreen use
• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• 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 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses.

KEEP OUT OF REACH OF CHILDREN

• children under 6 months: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Isoamyl Laurate, Sesamum Indicum (Sesame) Seed Oil, Oleic/Linoleic/Linolenic Polyglycerides, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Fruit Oil, Ricinus Communis (Castor) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Beeswax, Flavor*, Glyceryl Behenate, Glyceryl Stearate, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Dioctyldecyl Dimer Dilinoleate, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum Seed Butter, Glyceryl Caprylate, Propanediol, Tocopherol, Bisabolol, Glyceryl Undecylenate, Glycine Soja (Soybean) Oil, Ammonium Glycyrrhizate, Mica, Carmine, Titanium dioxide, Iron Oxides.

* Natural Flavor

Questions?

1-800-849-7112 or www.burtsbees.com

INDICATIONS & USAGE

Helps prevent sunburn

Apply as needed

For external use only

Do not use on damaged or broken skin

PRINCIPAL DISPLAY PANEL

image components

INGREDIENTS AND APPEARANCE

TINTED LIP BALM SPF30 WILD PEONY 
spf30 lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0357
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
YELLOW WAX (UNII: 2ZA36H0S2V)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
SHEA BUTTER (UNII: K49155WL9Y)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CASTOR OIL (UNII: D5340Y2I9G)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ARGAN OIL (UNII: 4V59G5UW9X)
ALMOND OIL (UNII: 66YXD4DKO9)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
SESAME OIL (UNII: QX10HYY4QV)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
VANILLA BEAN (UNII: Q74T35078H)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT (UNII: 3RT3536DHY)
JOJOBA OIL (UNII: 724GKU717M)
WHEAT GERM OIL (UNII: 14C97E680P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0357-1	1 g in 1 CYLINDER; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2022

Labeler - Autumn Harp (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp		064187883	manufacture(51514-0357)