EQUATE-SUNSCREEN BROAD SPECTRUM SPF 50 ULTRA- avobenzone homosalate octisalate octocrylene spray

Equate-Sunscreen Broad Spectrum SPF 50 ULTRA by

Drug Labeling and Warnings

Equate-Sunscreen Broad Spectrum SPF 50 ULTRA 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

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 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
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., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

PRINCIPAL DISPLAY PANEL

Equate-Sunscreen Broad Spectrum SPF 50 ULTRA Spray

INGREDIENTS AND APPEARANCE

EQUATE-SUNSCREEN BROAD SPECTRUM SPF 50 ULTRA 
avobenzone homosalate octisalate octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-979
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: 49035-979-37	156 g in 1 CAN; Type 0: Not a Combination Product	03/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/28/2019

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(49035-979)