TRUE BLUE SPA COOLING SUNSCREEN MIST BROAD SPECTRUM SPF 25 WATER RESISTANT (40 MINUTES) MONOI OIL- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone aerosol, spray

True Blue Spa Cooling Sunscreen Mist Broad Spectrum SPF 25 Water Resistant (40 minutes) Monoi Oil by

Drug Labeling and Warnings

True Blue Spa Cooling Sunscreen Mist Broad Spectrum SPF 25 Water Resistant (40 minutes) Monoi Oil by is a Otc medication manufactured, distributed, or labeled by Bath & Body Works, Inc., 220 Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 3.0%, Homosalate 13.5%, Octinoxate 7.5%, Octisalate 4.6%, Octocrylene 2.4%, 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.

FLAMMABLE

Keep away from flame or high heat.

• Contents under pressure.  Do not puncture or incinerate.  Do not store at temperatures above 120°F (50°C).

DO NOT USE

on damaged or broken skin.

WHEN USING THIS PRODUCT

• keep out of eyes.  Rinse with water to remove.
• keep away from face to avoid breathing in
• use only as directed.  Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure.  Hold container 4 to 6 inches from skin to apply.  Do not spray directly into face.  Spray on hands then apply to face.  Do not apply in windy conditions.  Use in a well ventilated area.
• Reapply:
• after 40 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 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

Isobutane, Alcohol Denat., Polyester-8, Acrylates/Octylacrylamide Copolymer, Cocos Nucifera (Coconut) Oil, Gardenia Tahitensis Flower, Tocopherol, Tocopheryl Acetate, Fragrance (Parfum), Dimethicone, Ethoxydiglycol, Butylene Glycol, Trisiloxane, Polyester-10, Propylene Glycol Dibenzoate.

COMPANY INFORMATION

Bath & Body Works, Distr.

Reynoldsburg, Ohio 43068

1-800-395-1001

www.bathandbodyworks.com

PRODUCT PACKAGING

INGREDIENTS AND APPEARANCE

TRUE BLUE SPA COOLING SUNSCREEN MIST BROAD SPECTRUM SPF 25 WATER RESISTANT (40 MINUTES) MONOI OIL 
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62670-8046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13.5 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.6 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.4 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6.0 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62670-8046-0	113 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/30/2013

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

Establishment
Name	Address	ID/FEI	Business Operations
220 Labs Inc.		783247950	manufacture(62670-8046)