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NDC 49035-0760-12 Equate 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

Equate 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

Equate is a TOPICAL LOTION 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	49035-0760
Product ID	49035-760_ec25f956-0368-b449-e053-2995a90a657a
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	LOTION
Route	TOPICAL
Active Ingredient Strength	30; 150; 50; 100; 60
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
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 49035-0760-12 (49035076012)

Pricing Information	N/A
NDC Package Code	49035-760-12
Billing NDC	49035076012
Package	236 mL in 1 TUBE (49035-760-12)
Marketing Start Date	2019-06-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8f24e301-3fce-f9e3-e053-2a95a90affe4 Details

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, 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

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 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

water, butylene glycol, microcrystalline cellulose, glyceryl stearate, behenyl alcohol, butylated PVP, benzyl alcohol, palmitic acid, myristyl alcohol, caprylic/capric triglyceride, stearic acid, lauryl alcohol, cetyl alcohol, sodium ascorbyl phosphate, tocopherol (vitamin E), lecithin, cellulose gum, chlorphenesin, disodium EDTA, fragrance.

Label

INGREDIENTS AND APPEARANCE

EQUATE SPF 70 ULTRA SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-760
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PALMITIC ACID (UNII: 2V16EO95H1)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLORPHENESIN (UNII: I670DAL4SZ)
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DOCOSANOL (UNII: 9G1OE216XY)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURYL ALCOHOL (UNII: 178A96NLP2)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-760-12	236 mL in 1 TUBE; Type 0: Not a Combination Product	06/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/04/2019

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 10/2022

Document Id: ec25f956-0368-b449-e053-2995a90a657a

Set id: 8f24e301-3fce-f9e3-e053-2a95a90affe4

Version: 2

Effective Time: 20221029