BATH AND BODY WORKS SPF WAIKIKI BEACH COCONUT- avobenzone,homosalate,octisalate,octocrylene lotion

Bath and Body Works SPF by

Drug Labeling and Warnings

Bath and Body Works SPF by is a Otc medication manufactured, distributed, or labeled by Bath & Body Works, Inc., KDC/ONE Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

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 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 immediately.

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 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-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

Inactive ingredients

Water (Aqua, Eau), Butyloctyl Salicylate, Glycerin, Styrene/Acrylates Copolymer, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, VP/Hexadecene Copolymer, Fragrance (Parfum), Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroxyacetophenone, Diethylhexyl 2,6-Naphthalate, PEG-8 Laurate, Chlorphenesin, Xanthan Gum, Oryza Sativa (Rice) Bran Extract, Tocopheryl Acetate, Sodium Hydroxide, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Hydroxycitronellal, Coumarin, Benzyl Salicylate, Limonene, Alpha-Isomethyl Ionone, Citronellol, Linalool.

Other information

protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Bath & Body Works, Distr.

95 West Main Street New Albany, OH 43054

1-800-395-1001

shop bathandbodyworks.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

BATH AND BODY WORKS SPF  WAIKIKI BEACH COCONUT
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-6688
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62670-6688-0	117 mg in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/12/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
KDC/ONE Chatsworth, Inc.		118542196	manufacture(62670-6688)