SIGNATURE SUNSCREEN BROAD SPECTRUM SPF 25 MALIBU HEAT- avobenzone, octinoxate, oxybenzone lotion

Signature Sunscreen Broad Spectrum SPF 25 Malibu Heat by

Drug Labeling and Warnings

Signature Sunscreen Broad Spectrum SPF 25 Malibu Heat by is a Otc medication manufactured, distributed, or labeled by Bath & Body Works, Inc., Cosmetic Labs of America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 3.0%, Octinoxate 7.5%, Oxybenzone 6.0%

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 swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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 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 of age: ask a doctor

OTHER INFORMATION

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

INACTIVE INGREDIENTS

Water (Aqua, Eau), C12-15 Alkyl Benzoate, Glycerin, Ethylhexyl Methoxycrylene, Fragrance (Parfum), Cocoglycerides, Dimethicone, Polyester-8, Diethylhexyl Syringylidenemalonate, VP/Eicosene Copolymer, Acrylates/Vinyl Neodecanoate Crosspolymer, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Gardenia Tahitensis Flower, Tocopherol, Tocopheryl Acetate, Ascorbyl Glucoside, Xanthan Gum, Cetyl Dimethicone, Glyceryl Stearate, Myristyl Myristate, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Chlorphenesin, Caprylic/Capric Triglyceride, Acrylates/Beheneth-25 Methacrylate Copolymer, Ethylhexylglycerin, Sodium Stearoyl Lactylate, Disodium EDTA, Sodium PCA, Sodium Hydroxide, Phenoxyethanol, Methylisothiazolinone.

COMPANY INFORMATION

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

PRODUCT PACKAGING

INGREDIENTS AND APPEARANCE

SIGNATURE SUNSCREEN BROAD SPECTRUM SPF 25 MALIBU HEAT 
avobenzone, octinoxate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-8045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6.0 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62670-8045-5	177 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/09/2013

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Labs of America		013696501	manufacture(62670-8045)