EQUATE SUNSCREEN SPORT SPF 100- avobenzone homosalate octisalate octocrylene oxybenzone lotion

Equate Sunscreen SPORT SPF 100 by

Drug Labeling and Warnings

Equate Sunscreen SPORT SPF 100 by is a Otc medication manufactured, distributed, or labeled by Walmart Stores Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Oxybenzone 6.0%

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 product is 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

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

children under 6 months: 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

water, propylene glycol, styrene/acrylates copolymer, behenyl alcohol, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, myristyl alcohol, stearic acid, hydrolyzed wheat protein/PVP crosspolymer, lauryl alcohol, cetyl alcohol, tocopherol (vitamin E), sodium ascorbyl phosphate (vitamin C phosphate), lecithin, cellulose gum, fragrance, butylated PVP, disodium EDTA, caprylyl glycol, ethylhexyl glycerin, phenoxyethanol

PRINCIPAL DISPLAY PANEL

Equate Sunscreen Sport SPF 100 Lotion

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN SPORT SPF 100 
avobenzone homosalate octisalate octocrylene oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-789
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	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
LAURYL ALCOHOL (UNII: 178A96NLP2)
CETYL ALCOHOL (UNII: 936JST6JCN)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DOCOSANOL (UNII: 9G1OE216XY)
POVIDONE (UNII: FZ989GH94E)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-789-15	177 mL in 1 TUBE; Type 0: Not a Combination Product	02/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/13/2019

Labeler - Walmart Stores Inc. (051957769)

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth, Inc.		080086802	manufacture(49035-789)