Tinted Lip Balm SPF30 Sienna Rose

Tinted Lip Balm SPF30 Sienna Rose by

Drug Labeling and Warnings

Tinted Lip Balm SPF30 Sienna Rose by is a Otc medication manufactured, distributed, or labeled by Burt's Bees Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TINTED LIP BALM SPF30 SIENNA ROSE- spf30 lip balm stick 
Burt's Bees Inc.

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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Tinted Lip Balm SPF30 Sienna Rose

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 useon damaged or broken skin.

When using this product keep out of eyes. Rinse with water ro remove.

Stop use and ask a doctor if rash occurs.

Directions

• For suncscreen 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.
• children under 6 months: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Sesamum Indicum (Sesame) Seed Oil, Oleic/Linoleic/Linolenic Polyglycerides, Isoamyl Laurate, 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, Carmine, Iron Oxides.

* Natural Flavor

Questions?

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

TINTED LIP BALM SPF30 SIENNA ROSE 
spf30 lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-100
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
JOJOBA OIL (UNII: 724GKU717M)
WHEAT GERM OIL (UNII: 14C97E680P)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
SOYBEAN OIL (UNII: 241ATL177A)
VANILLA BEAN (UNII: Q74T35078H)
SESAME OIL (UNII: QX10HYY4QV)
CASTOR OIL (UNII: D5340Y2I9G)
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PIGMENT RED 48 (UNII: 07XHK4SAV6)
SHEA BUTTER (UNII: K49155WL9Y)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
COCONUT (UNII: 3RT3536DHY)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALMOND OIL (UNII: 66YXD4DKO9)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ARGAN OIL (UNII: 4V59G5UW9X)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-100-01	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 final	part352	03/01/2022

Labeler - Burt's Bees Inc. (613480946)

Revised: 1/2023

Document Id: f213e192-d216-2cd0-e053-2a95a90a32f5

34390-5

Set id: cfbfbda1-0402-915c-e053-2a95a90a72c8

Version: 2

Effective Time: 20230112