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

Sunscreen ULTRA Broad Spectrum by

Drug Labeling and Warnings

Sunscreen ULTRA Broad Spectrum 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 7.0%

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

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

apply liberally 15 minutes before sun exposure

   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, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexyl glycerin, sorbitan isostearate, benzyl alcohol, fragrance

PRINCIPAL DISPLAY PANEL

Equate Sunscreen Ultra Broad Spectrum SPF 50 Lotion

16 FL OZ (473 ML)

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN ULTRA BROAD SPECTRUM SPF 50 
avobenzone homosalate octisalate octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-566
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	130 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
POLYETHYLOXAZOLINE (200000 MW) (UNII: I765I75FT2)
CARBOMER 934 (UNII: Z135WT9208)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-566-14	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/21/2019

Labeler - Walmart 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(49035-566)