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NDC 49035-0753-42 Equate 40; 50.2125 mg/mL; mg/mL Details

Equate 40; 50.2125 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 OCTOCRYLENE; ZINC OXIDE.

Product Information

NDC	49035-0753
Product ID	49035-753_ec23b466-92c2-a8cf-e053-2995a90a9053
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 Ultra Zinc Sunscreen
Non-Proprietary Name	Octocrylene, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	40; 50.2125
Active Ingredient Units	mg/mL; mg/mL
Substance Name	OCTOCRYLENE; ZINC OXIDE
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 49035-0753-42 (49035075342)

Pricing Information	N/A
NDC Package Code	49035-753-42
Billing NDC	49035075342
Package	29.6 mL in 1 JAR (49035-753-42)
Marketing Start Date	2019-08-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8fdc0bad-8834-5b4a-e053-2a95a90a9fde Details

Active ingredients

Octocrylene 4%, Zinc Oxide 5%

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, ethylhexyl stearate, diisopropyl adipate, cetyl dimethicone, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, phenoxyethanol, beeswax, isohexadecane, hydrogenated castor oil, fragrance, silica, triethoxycaprylylsilane, dimethicone, tocopherol (Vitamin E), tetrasodium EDTA, aloe barbadensis leaf juice, sodium chloride, sodium ascorbyl phosphate.

Label

INGREDIENTS AND APPEARANCE

EQUATE SPF 50 ULTRA ZINC SUNSCREEN

octocrylene, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-753
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50.2125 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
EDETATE SODIUM (UNII: MP1J8420LU)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-753-42	29.6 mL in 1 JAR; 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: ec23b466-92c2-a8cf-e053-2995a90a9053

Set id: 8fdc0bad-8834-5b4a-e053-2a95a90a9fde

Version: 3

Effective Time: 20221028