FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREEN- avobenzone, homosalate, octocrylene aerosol, spray

FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREEN by

Drug Labeling and Warnings

FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 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

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

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 casued by the sun

Warnings

For external use only

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
• 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-sleeve shirts, pants, hats, and sunglasses

Other information

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

Inactive ingredients

alcohol denat., isododecane, fragrance, diisopropyl adipate, acrylates/octylacrylamide copolymer, VA/butyl maleate/isobornyl acrylate copolymer, PEG-12 dimethicone, caprylyl glycol, hydrogenated methyl abietate, honey (manuka honey), bertholletia excelsa seed oil (brazil nut), vaccinium macrocarpon (cranberry) seed oil, ascorbyl palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract.

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY & ESSENTIAL OILS SPF 30 SUNSCREEN CONTINUOUS SPRAY

5.5 OZ (156g)

NDC: 62217-041-37

FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY & ESSENTIAL OILS SPF 30 SUNSCREEN CONTINUOUS SPRAY

2.7 OZ (76.5g)

NDC: 62217-041-74

INGREDIENTS AND APPEARANCE

FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREEN 
avobenzone, homosalate, octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ISODODECANE (UNII: A8289P68Y2)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
HONEY (UNII: Y9H1V576FH)
BRAZIL NUT (UNII: XKR79OET1K)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MINERAL OIL (UNII: T5L8T28FGP)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-041-37	156 g in 1 CAN; Type 0: Not a Combination Product	07/24/2018
2	NDC: 62217-041-74	76.5 g in 1 CAN; Type 0: Not a Combination Product	04/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/24/2018

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(62217-041)