BURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAM stick BURTS BEES SPF 30 UNTINTED LIP BALM TROPIC LIKE ITS HOT stick BURTS BEES SPF 30 UNTINTED LIP BALM COCO LOCO stick

Burts Bees SPF 30 Untinted Lip Balm Coco Loco by

Drug Labeling and Warnings

Burts Bees SPF 30 Untinted Lip Balm Coco Loco by is a Otc medication manufactured, distributed, or labeled by Autumn Harp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 12% - Sunscreen

PURPOSE

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.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 15 or higher and other sun protection measures, including:

- limit time in the sun, especially from 10 a.m.-2 p.m.

- wear long-sleeved shirts, pants, hats and sunglasses.

- children under 6 months: Ask a doctor.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

Beaches and Cream - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Natural Fragrance, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Glyceryl Undecylenate.

Tropic Like It's Hot - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Natural Fragrance, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Orange Oil Terpenes, Limonene, Linalool, Glyceryl Undecylenate, Amyl Cinnamal.

Coco Loco - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Citrus Aurantium Dulcis (Orange) Peel Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Ricinus Communis (Castor) Seed Oil, Curcuma Longa (Turmeric) Root Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Natural Fragrance, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Limonene, Glyceryl Undecylenate, Amyl Cinnamal, Benzyl Salicylate, Hydroxycitronellal, Eugenol, Linalool.

QUESTIONS

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAM 
burts bees spf 30 untinted lip balm beaches and cream stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0369
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.99 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
CANDELILLA WAX (UNII: WL0328HX19)
ISOSTEARIC ACID (UNII: X33R8U0062)
CASTOR OIL (UNII: D5340Y2I9G)
WHITE WAX (UNII: 7G1J5DA97F)
ARGAN OIL (UNII: 4V59G5UW9X)
SOYBEAN OIL (UNII: 241ATL177A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
JOJOBA OIL (UNII: 724GKU717M)
FRAGRANCE 13576 (UNII: 5EM498GW35)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0369-2	1 in 1 CARTON	06/01/2024
1	NDC: 51514-0369-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2024

BURTS BEES SPF 30 UNTINTED LIP BALM TROPIC LIKE ITS HOT 
burts bees spf 30 untinted lip balm tropic like its hot stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.99 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
ALMOND OIL (UNII: 66YXD4DKO9)
CANDELILLA WAX (UNII: WL0328HX19)
ISOSTEARIC ACID (UNII: X33R8U0062)
CASTOR OIL (UNII: D5340Y2I9G)
WHITE WAX (UNII: 7G1J5DA97F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ARGAN OIL (UNII: 4V59G5UW9X)
SOYBEAN OIL (UNII: 241ATL177A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SHEA BUTTER (UNII: K49155WL9Y)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
JOJOBA OIL (UNII: 724GKU717M)
FRAGRANCE 13576 (UNII: 5EM498GW35)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ORANGE OIL (UNII: AKN3KSD11B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0370-2	1 in 1 CARTON	06/01/2024
1	NDC: 51514-0370-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2024

BURTS BEES SPF 30 UNTINTED LIP BALM COCO LOCO 
burts bees spf 30 untinted lip balm coco loco stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.99 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CLOVE OIL (UNII: 578389D6D0)
NUTMEG OIL (UNII: Z1CLM48948)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
TURMERIC OIL (UNII: 6KGS8SP16U)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ALMOND OIL (UNII: 66YXD4DKO9)
CANDELILLA WAX (UNII: WL0328HX19)
ISOSTEARIC ACID (UNII: X33R8U0062)
CASTOR OIL (UNII: D5340Y2I9G)
WHITE WAX (UNII: 7G1J5DA97F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ARGAN OIL (UNII: 4V59G5UW9X)
SOYBEAN OIL (UNII: 241ATL177A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SHEA BUTTER (UNII: K49155WL9Y)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
JOJOBA OIL (UNII: 724GKU717M)
FRAGRANCE 13576 (UNII: 5EM498GW35)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
EUGENOL (UNII: 3T8H1794QW)
ORANGE OIL (UNII: AKN3KSD11B)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0371-2	1 in 1 CARTON	06/01/2024
1	NDC: 51514-0371-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2024

Labeler - Autumn Harp (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp		064187883	manufacture(51514-0369, 51514-0370, 51514-0371)