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

SPORT SPF 50 SUNSCREEN by

Drug Labeling and Warnings

SPORT SPF 50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by THE KROGER COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Purpose

Sunscreen

INDICATIONS & USAGE

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 aboce 104ºF (40ºC)

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 120ºF.

STOP USE

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 to 6 inches away from skin to apply
• do not spray directly into face. Spray into hand then apply to face.
• do not apply in windy conditions
• use in a well-ventillated 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. (73.2% v/v), acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride

Questions or comments?

1-800-632-6900

PRINCIPAL DISPLAY PANEL

KROGER SPORT SPF 50 SUNSCREEN CONTINUOUS SPRAY

5.5 OZ (156g)

30142-885-37

KROGER SPORT SPF 50 SUNSCREEN CONTINUOUS SPRAY

9.1 OZ (258g)

30142-885-48

KROGER SPORT SPF 50 SUNSCREEN CONTINUOUS SPRAY TWIN PACK

2x 5.5 OZ

30142-885-63

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-885
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-885-63	2 in 1 PACKAGE	11/07/2018
1	NDC: 30142-885-37	156 g in 1 CAN; Type 0: Not a Combination Product
2	NDC: 30142-885-48	258 g in 1 CAN; Type 0: Not a Combination Product	03/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/24/2018

Labeler - THE KROGER COMPANY (006999528)

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(30142-885)