FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN- homosalate, octisalate aerosol, spray

FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN by

Drug Labeling and Warnings

FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by FRUIT OF THE EARTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 7.0%, Octisalate 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

FLAMMABLE:

• do not use near heat, flame or while smoking
• avoid long term storage above 104°F (40°C)

DO NOT USE

Do not use  on damaged or broken skin.

WHEN USING

When using this product  keep out of eyes. Rinse with water to remove  keep away from face to avoid breathing it.  do not puncture or incinerate. Contents under pressure.  do not store at temperatures above 120°F.

ASK DOCTOR

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 contact a Poison Control Center right away.

Directions

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

    after 80 minutes of swimming or sweating

    immediately after towel drying

    at least every 2 hours

• Children under 6 months of age: ask a doctor

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

alcohol denat., fragrance, acrylates/octylacrylamide copolymer, citrus sinensis (blood orange) oil, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, tocopheryl acetate, mineral oil, tridecyl salicylate

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

FRUIT OF THE EARTH CABANA BEACH CLUB WITH BLOOD ORANGE & ESSENTIAL OILS SPF 8 DRY TANNING OIL SPRAY SUNSCREEN

5.5 OZ (156g)

NDC: 62217-043-37

FRUIT OF THE EARTH CABANA BEACH CLUB WITH BLOOD ORANGE & ESSENTIAL OILS SPF 8 DRY TANNING OIL SPRAY SUNSCREEN

2.7 OZ (76.5g)

NDC: 62217-043-74

INGREDIENTS AND APPEARANCE

FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN 
homosalate, octisalate aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
MINERAL OIL (UNII: T5L8T28FGP)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
LIME OIL (UNII: UZH29XGA8G)
ORANGE OIL (UNII: AKN3KSD11B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-043-37	156 g in 1 CAN; Type 0: Not a Combination Product	01/15/2019
2	NDC: 62217-043-74	76.5 g in 1 CAN; Type 0: Not a Combination Product	04/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/15/2019

Labeler - FRUIT OF THE EARTH, INC. (079559467)

Registrant - FRUIT OF THE EARTH, INC. (008193513)

Establishment
Name	Address	ID/FEI	Business Operations
FRUIT OF THE EARTH, INC.		079559467	manufacture(62217-043)