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

Equate Sunscreen SPF 50 BABY by

Drug Labeling and Warnings

Equate Sunscreen SPF 50 BABY 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 13.0%
Octisalate 5.0%
Octocrylene 2.0%

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
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

water, butyloctyl salicylate, sorbitol, VP/eicosene copolymer, stearic acid, aloe barbadensis leaf juice, panthenol, tocopherol, sorbitan isostearate, dimethicone, polyglyceryl-3 distearate, disodium EDTA, acrylates/C10-30 alkyl acrylate crosspolymer, styrene/acrylates copolymer, triethanolamine, benzyl alcohol, phenoxyethanol, capryloyl glycine, undecylenoyl glycine

PRINCIPAL DISPLAY PANEL

Equate Sunscreen SPF 50 BABY Broad Spectrum Spray

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN SPF 50 BABY  BROAD SPECTRUM
avobenzone, homosalate,octisalate,octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-893
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	130 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SORBITOL (UNII: 506T60A25R)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-893-50	178 g in 1 CAN; Type 0: Not a Combination Product	01/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/25/2019

Labeler - WAL-MART STORES INC (051957769)

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth, Inc.		080086802	manufacture(49035-893)