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NDC 49035-0765-37 Equate 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g Details

Equate 30; 150; 50; 40; 60 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	49035-0765
Product ID	49035-765_ec365186-0378-5ee0-e053-2995a90a9d6d
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 70 Ultra Sunscreen
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 150; 50; 40; 60
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 49035-0765-37 (49035076537)

Pricing Information	N/A
NDC Package Code	49035-765-37
Billing NDC	49035076537
Package	156 g in 1 CANISTER (49035-765-37)
Marketing Start Date	2019-08-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9b655e56-33e5-45a3-9174-356fc717e39d Details

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 4.0%, 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 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

acrylates/octyacrylamide copolymer, alcohol denat., argania spinosa seedcake extract, butylene glycol, fragrance, octydodecyl neopentanoate, tocopherol acetate, water.

Label

INGREDIENTS AND APPEARANCE

EQUATE SPF 70 ULTRA SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-765
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 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)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-765-37	156 g in 1 CANISTER; Type 0: Not a Combination Product	08/12/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/12/2019

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 10/2022

Document Id: ec365186-0378-5ee0-e053-2995a90a9d6d

Set id: 9b655e56-33e5-45a3-9174-356fc717e39d

Version: 3

Effective Time: 20221029

Search by Drug Name or NDC

NDC 49035-0765-37 Equate 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g Details

Equate 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 49035-0765-37 (49035076537)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9b655e56-33e5-45a3-9174-356fc717e39d Details

Active ingredients

Purpose

Uses

Warnings

FLAMMABLE

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Label

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?

Search by Drug Name or NDC

NDC 49035-0765-37 Equate 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g Details

Equate 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 49035-0765-37 (49035076537)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9b655e56-33e5-45a3-9174-356fc717e39d Details

Active ingredients

Purpose

Uses

Warnings

FLAMMABLE

Do not use

When using this product ​

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Label

INGREDIENTS AND APPEARANCE

When using this product