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NDC 49035-0849-37 Equate Sunscreen SPF70 ULTRA 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g Details

Equate Sunscreen SPF70 ULTRA 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g

Equate Sunscreen SPF70 ULTRA 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	49035-0849
Product ID	49035-849_ec4479f0-2dda-72b5-e053-2995a90aa7c1
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 Sunscreen SPF70 ULTRA
Proprietary Name Suffix	Broad spectrum
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 49035-0849-37 (49035084937)

Pricing Information	N/A
NDC Package Code	49035-849-37
Billing NDC	49035084937
Package	156 g in 1 CAN (49035-849-37)
Marketing Start Date	2017-11-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 91bed77e-6fa1-40bf-9f3d-5303855a22cf Details

Active Ingredient

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 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 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/octylacrylamide copolymer, butylene glycol, argania spinosa seedcake extract, octyldodecyl neopentanoate,

tocopheryl acetate, fragrance

Label

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN SPF70 ULTRA BROAD SPECTRUM

avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-849
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-849-37	156 g in 1 CAN; Type 0: Not a Combination Product	11/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/08/2017

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 10/2022

Document Id: ec4479f0-2dda-72b5-e053-2995a90aa7c1

Set id: 91bed77e-6fa1-40bf-9f3d-5303855a22cf

Version: 6

Effective Time: 20221030