BATH AND BODY WORKS SPF20 COCONUT LIP BALM- spf20 lip balm stick

Bath and Body Works SPF20 Coconut Lip Balm by

Drug Labeling and Warnings

Bath and Body Works SPF20 Coconut Lip Balm 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

Avobenzone 2.5%

Homosolate 10%

Octisalate 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.

DOSAGE & ADMINISTRATION

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

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
• after 80 minutes of swimming or sweating
• Immediately after towel drying
• 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 value of 15 or higher and other sun protection meansures including:

• limit time in the sun, especially from 10 am - 2 pm
• wear long-sleeved shirts, pants, hats and sunglasses
• Children under 6 months of age: ask a doctor

Other Information

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

Inactive Ingredients

Cocous nucifera (coconut) oil, Ricinus communis (Castor) seed oil, Helianthus annuus (Sunflower) seed oil, Beeswax (cera alba, cire l'abeille), Euphorbia cerifera (candelilla) wax (candelilla cera, cire de candelilla), Butyrospermum parkii (Shea) butter, Hydrogenated coco-glycerides, Copernicia cerifera (carnauba) wax (cera carnauba, cire de carnauba), flavor (aroma), Garcinia indica seed butter, Limnathes alba (meadowfoarm) seed oil, Tocopherol, Stevia rebaudiana extract, Lauroyl lysine, Mica.

QUESTIONS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BATH AND BODY WORKS SPF20 COCONUT LIP BALM 
spf20 lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0360
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
TOCOPHEROL (UNII: R0ZB2556P8)
STEVIA LEAF (UNII: 6TC6NN0876)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LAUROYL LYSINE (UNII: 113171Q70B)
BENZYL BENZOATE (UNII: N863NB338G)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
CASTOR OIL (UNII: D5340Y2I9G)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0360-1	100 mg in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2022

Labeler - Autumn Harp (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp		064187883	manufacture(51514-0360)