BATH AND BODY WORKS SPF 35 SUMMER CRUSH LIP BALM stick BATH AND BODY WORKS SPF 35 NATURAL LIP BALM stick BATH AND BODY WORKS SPF 35 BERRY LIP BALM stick

Bath and Body Works SPF 35 Berry Lip Balm by

Drug Labeling and Warnings

Bath and Body Works SPF 35 Berry Lip Balm by is a Otc medication manufactured, distributed, or labeled by Bath and Body Works, Inc., Autumn Harp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone - 2.5%

Octisalate - 5%

Homosalate - 10%

PURPOSE

Avobenzone - Sunscreen

Octisalate - Sunscreen

Homosalate - Sunscreen

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposire. Reapply:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

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

INSTRUCTIONS FOR USE

Limit time in the sun, especially from 10am-2pm

Wear long sleeved shirts, pants, hats and sunglasses

Childresn under 6 months of age, ask doctor

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

QUESTIONS

1-800-395-1001

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BATH AND BODY WORKS SPF 35 SUMMER CRUSH LIP BALM 
bath and body works spf 35 summer crush lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-6609
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
SOYBEAN OIL (UNII: 241ATL177A)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SHEA BUTTER (UNII: K49155WL9Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ANISE OIL (UNII: 6Y89129C8H)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAUROYL LYSINE (UNII: 113171Q70B)
COCOA BUTTER (UNII: 512OYT1CRR)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62670-6609-1	4 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/22/2024

BATH AND BODY WORKS SPF 35 NATURAL LIP BALM 
bath and body works spf 35 natural lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-6607
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SHEA BUTTER (UNII: K49155WL9Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ANISE OIL (UNII: 6Y89129C8H)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAUROYL LYSINE (UNII: 113171Q70B)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
COCOA BUTTER (UNII: 512OYT1CRR)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
SOYBEAN OIL (UNII: 241ATL177A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62670-6607-1	4 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/22/2024

BATH AND BODY WORKS SPF 35 BERRY LIP BALM 
bath and body works spf 35 berry lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-6608
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SHEA BUTTER (UNII: K49155WL9Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ANISE OIL (UNII: 6Y89129C8H)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAUROYL LYSINE (UNII: 113171Q70B)
COCOA BUTTER (UNII: 512OYT1CRR)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
SOYBEAN OIL (UNII: 241ATL177A)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62670-6608-1	4 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/22/2024

Labeler - Bath and Body Works, Inc. (878952845)

Registrant - Autumn Harp (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp		064187883	manufacture(62670-6607, 62670-6608, 62670-6609)