EQUATE TANNING SUNSCREEN DRY OIL UVB PROTECTION SPF10- homosalate, octisalate spray

EQUATE Tanning Sunscreen Dry oil UVB Protection SPF10 by

Drug Labeling and Warnings

EQUATE Tanning Sunscreen Dry oil UVB Protection SPF10 by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 7.0%

Octisalate 5.0%

Purpose

Sunscreen

Uses

helps prevent sunburn

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

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

  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 it. do not puncture or incinerate. Contents under pressure. do not store at temperatures above 120° F

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 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., tridecyl salicylate, acrylates/octylacrylamide copolymer, fragrance, mineral oil.

PRINCIPAL DISPLAY PANEL

Equate Tanning Sunscreen Dry Oil UVB Protection SPF 10 Spray

INGREDIENTS AND APPEARANCE

EQUATE TANNING SUNSCREEN DRY OIL UVB PROTECTION SPF10 
homosalate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-787
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)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-787-37	156 g in 1 CAN; Type 0: Not a Combination Product	04/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/18/2019

Labeler - Wal-Mart Stores Inc (051957769)

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(49035-787)