EQUATE SUNSCREEN KIDS SPF50 BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene spray

Equate Sunscreen KIDS SPF50 by

Drug Labeling and Warnings

Equate Sunscreen KIDS SPF50 by is a Otc medication manufactured, distributed, or labeled by WAL-MART STORES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

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 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

alcohol denat., isododecane, diisopropyl adipate, acrylates/octylacrylamide copolymer, VA/butyl maleate/isobornyl acrylate copolymer, PEG-12 dimethicone, caprylyl glycol, hydrogenated methyl abietate, ascorbyl palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract, fragrance

PRINCIPAL DISPLAY PANEL

Equate Sunscreen Kids SPF 50 Broad Spectrum Spray

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN KIDS SPF50  BROAD SPECTRUM
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-845
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MINERAL OIL (UNII: T5L8T28FGP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PANTHENOL (UNII: WV9CM0O67Z)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
VINYL ACETATE (UNII: L9MK238N77)
ISODODECANE (UNII: A8289P68Y2)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-845-37	156 g in 1 CAN; Type 0: Not a Combination Product	01/21/2019
2	NDC: 49035-845-39	312 g in 1 CAN; Type 0: Not a Combination Product	01/21/2019
3	NDC: 49035-845-48	258 g in 1 CAN; Type 0: Not a Combination Product	01/21/2019
4	NDC: 49035-845-78	516 g in 1 CAN; Type 0: Not a Combination Product	12/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/21/2019

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(49035-845)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth, Inc.		080086802	manufacture(49035-845)