EQUATE SPF 50 ULTRA ZINC SUNSCREEN- octocrylene, zinc oxide lotion

Equate by

Drug Labeling and Warnings

Equate by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Walmart Equate SPF 50 Ultra Zinc Sunscreen Lotion – Drug Facts

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

Do not use on damaged or broken skin.

WHEN USING

When using this product ​ keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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 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-sleeve shirts, pants, hats, and sunglasses

Other information

• protect this product 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.

Walmart Equate SPF 50 Ultra Zinc Sunscreen Lotion

1 FL OZ (29.6)

NDC: 49035-753-42

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-753-42	29.6 mL in 1 JAR; Type 0: Not a Combination Product	08/12/2019

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

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(49035-753)