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NDC 49035-0139-63 Equate 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g Details

Equate 30; 100; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g

Equate is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	49035-0139
Product ID	49035-139_c7433d49-32a4-0c01-e053-2a95a90a2d48
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Equate
Proprietary Name Suffix	SPF 50 Sport Sunscreen
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 40; 50
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0139-63 (49035013963)

Pricing Information	N/A
NDC Package Code	49035-139-63
Billing NDC	49035013963
Package	2 CANISTER in 1 PACKAGE (49035-139-63) / 156 g in 1 CANISTER (49035-139-37)
Marketing Start Date	2012-07-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 949554f3-239f-9b84-e053-2995a90a30a9 Details

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 5.0%

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 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 104ºF (40ºC)

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 120ºF.

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 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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

protect the product in this container from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

Inactive ingredients

alcohol denat., acrylates/octyacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate) caprylic/capric triglyceride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUATE SPF 50 SPORT SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-139
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-139-63	2 in 1 PACKAGE	07/06/2012
1	NDC:49035-139-37	156 g in 1 CANISTER; Type 0: Not a Combination Product
2	NDC:49035-139-48	258 g in 1 CANISTER; Type 0: Not a Combination Product	07/06/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/06/2012

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 7/2021

Document Id: c7433d49-32a4-0c01-e053-2a95a90a2d48

Set id: 949554f3-239f-9b84-e053-2995a90a30a9

Version: 3

Effective Time: 20210716