SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene aerosol, spray

SPF 50 SUNSCREEN by

Drug Labeling and Warnings

SPF 50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by DEMOULAS SUPER MARKETS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%

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:

    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 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

Other information

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

Inactive ingredients

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol (provitamin B5), tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

MARKET BASKET SPORT SPF 50 SUNSCREEN CONTINUOUS SPRAY

5.5 OZ (156g)

NDC: 53942-001-37

INGREDIENTS AND APPEARANCE

SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-001-37	156 g in 1 CAN; Type 0: Not a Combination Product	03/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/30/2016

Labeler - DEMOULAS SUPER MARKETS, INC (007869647)

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

Establishment
Name	Address	ID/FEI	Business Operations
FRUIT OF THE EARTH, INC.		080086802	manufacture(53942-001)