BBW SPF 35 PINK DREAM LIP BALM stick BBW SPF 35 BERRY LIP BALM stick BBW SPF 35 NATURAL LIP BALM stick

BBW SPF 35 Natural Lip Balm by

Drug Labeling and Warnings

BBW SPF 35 Natural Lip Balm by is a Otc medication manufactured, distributed, or labeled by Autumn Harp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.5%

Homosalate 10%

Octisalate 5%

PURPOSE

Avobenzone - Sunscreen

Homosalate - Sunscreen

Octisalate - Sunscreen

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. 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 domaged or broken skin

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

Sop use and ask a doctor if rash occurs

INSTRUCTIONS FOR USE

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

OTHER SAFETY INFORMATION

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

Wear long sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: ask a doctor

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 skin 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

BBW SPF 35 PINK DREAM LIP BALM 
bbw spf 35 pink dream lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0367
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
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
LAUROYL LYSINE (UNII: 113171Q70B)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CASTOR OIL (UNII: D5340Y2I9G)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICA (UNII: V8A1AW0880)
SOYBEAN OIL (UNII: 241ATL177A)
CANDELILLA WAX (UNII: WL0328HX19)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CARNAUBA WAX (UNII: R12CBM0EIZ)
BENZYL BENZOATE (UNII: N863NB338G)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
ANISE OIL (UNII: 6Y89129C8H)
COCONUT OIL (UNII: Q9L0O73W7L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0367-1	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

BBW SPF 35 BERRY LIP BALM 
bbw spf 35 berry lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0366
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
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
LAUROYL LYSINE (UNII: 113171Q70B)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CASTOR OIL (UNII: D5340Y2I9G)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICA (UNII: V8A1AW0880)
SOYBEAN OIL (UNII: 241ATL177A)
CANDELILLA WAX (UNII: WL0328HX19)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CARNAUBA WAX (UNII: R12CBM0EIZ)
BENZYL BENZOATE (UNII: N863NB338G)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
ANISE OIL (UNII: 6Y89129C8H)
COCONUT OIL (UNII: Q9L0O73W7L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0366-1	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

BBW SPF 35 NATURAL LIP BALM 
bbw spf 35 natural lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0365
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
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
LAUROYL LYSINE (UNII: 113171Q70B)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CASTOR OIL (UNII: D5340Y2I9G)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICA (UNII: V8A1AW0880)
SOYBEAN OIL (UNII: 241ATL177A)
CANDELILLA WAX (UNII: WL0328HX19)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CARNAUBA WAX (UNII: R12CBM0EIZ)
BENZYL BENZOATE (UNII: N863NB338G)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
ANISE OIL (UNII: 6Y89129C8H)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0365-1	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 - Autumn Harp (064187883)

Registrant - Autumn Harp (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp		064187883	manufacture(51514-0365, 51514-0366, 51514-0367)