EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene. lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Available from:
Wal-Mart Stores Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen • 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 rash occurs.
Authorization status:
OTC monograph not final
Authorization number:
49035-797-11, 49035-797-44, 49035-797-49

EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM- avobenzone, homosalate,

octisalate, octocrylene. lotion

Wal-Mart Stores Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Equate Sunscreen SPF 50 SPORT Broad Spectrum Lotion

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 4.5%

Octocrylene 8.0%

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, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, aluminum

starch octenylsuccinate, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax,

ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin

E), arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA,

sodium ascorbyl phosphate, fragrance.

Equate Sunscreen SPF 50 SPORT Broad Spectrum Lotion

EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM

avobenzone, homosalate, octisalate, octocrylene. lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-79 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 mg in 1 mL

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

10 0 mg in 1 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

45 mg in 1 mL

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

8 0 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PO LYESTER-7 (UNII: 0 8 416 9 8 D2F)

NEO PENTYL GLYCO L DIHEPTANO ATE (UNII: 5LKW3C543X)

GLYCERIN (UNII: PDC6 A3C0 OX)

STYRENE/ACRYLAMIDE CO PO LYMER ( 50 0 0 0 0 MW) (UNII: 5Z4DPO246 A)

ALUMINUM STARCH O CTENYLSUCCINATE (UNII: I9 PJ0 O6 29 4)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

ARACHIDYL ALCO HO L (UNII: 1QR1QRA9 BU)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

( C10 -C3 0 ) ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38 D8 )

TO CO PHERO L (UNII: R0 ZB2556 P8 )

ARACHIDYL GLUCO SIDE (UNII: 6 JVW35JOOJ)

GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

DO CO SANO L (UNII: 9 G1OE216 XY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 0 35-79 7-11

237 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 2/20 19

2

NDC:49 0 35-79 7-44

9 46 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 2/20 19

3

NDC:49 0 35-79 7-49

44.4 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 2/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 4/30 /20 19

Wal-Mart Stores Inc

Labeler -

Wal-Mart Stores Inc (051957769)

Registrant -

FRUIT OF T HE EART H, INC. (079559467)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fruit Of The Earth, Inc.

0 8 0 0 8 6 8 0 2

ma nufa c ture (49 0 35-79 7)

Revised: 12/2019

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