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

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:
49035-979-37

EQUATE-SUNSCREEN BROAD SPECTRUM SPF 50 ULTRA- avobenzone homosalate

octisalate octocrylene spray

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 Broad Spectrum SPF 50 ULTRA Spray

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

Equate-Sunscreen Broad Spectrum SPF 50 ULTRA Spray

EQUATE-SUNSCREEN BROAD SPECTRUM SPF 50 ULTRA

avobenzone homosalate octisalate octocrylene spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-9 79

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 g

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

HOMOSALATE

10 0 mg in 1 g

Wal-Mart Stores Inc

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

OCTISALATE

50 mg in 1 g

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

OCTOCRYLENE

40 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

ACRYLATE/ISO BUTYL METHACRYLATE/N-TERT-O CTYLACRYLAMIDE CO PO LYMER ( 7 50 0 0 MW) (UNII:

JU3XHR8 VWK)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

STEARO XYTRIMETHYLSILANE (UNII: 9 8 6 2TW9 4B2)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 0 35-9 79 -37

156 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 3/28 /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 3/28 /20 19

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 Research Labo rato ries, Inc.

0 0 8 19 3513

ma nufa c ture (49 0 35-9 79 )

Revised: 12/2019

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