EQUATE SUNSCREEN MINERAL BASED KIDS BROAD SPECTRUM SPF 50- homosalate , octocrylene, zinc oxide stick

Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50 by

Drug Labeling and Warnings

Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50 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

Homosalate 5.0%,

Octocrylene 10.0%,

Zinc Oxide 15.0%

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 skin 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 product is swallowed, get medical help or contact a Poison Control 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

SPL UNCLASSIFIED SECTION

Equate Mineral-Based Sunscreen Stick SPF 50 glides on easily to provide broad spectrum UVA/UVB protection that protects kids’ sensitive skin. This non-greasy sunscreen goes on quickly without a sticky residue to keep active kids moving. This hypoallergenic formula helps you keep your kids’ skin safe while on the move

Inactive ingredients

caprylic/capric triglyceride, ozokerite, theobroma cacao (cocoa) seed butter, lauryl laurate, BIS-PEG-dimethicone beeswax, C12-15 alkyl benzoate, tridecyl salicylate, synthetic beeswax

PRINCIPAL DISPLAY PANEL

Equate

Sunscreen

Mineral Based SPF 50

KIDS

Broad Spectrum spf 50

Water resistant (80 minutes)

Pediatrician tested

OCTINOXATE, OXYBENZONE Free

NET WT 1.5 OZ (42 g)

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN MINERAL BASED KIDS BROAD SPECTRUM SPF 50 
homosalate , octocrylene, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-962
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
LAURYL LAURATE (UNII: GPW77G0937)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-962-28	42 g in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/26/2019

Labeler - Wal-Mart Stores Inc (051957769)

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth, Inc.		080086802	manufacture(49035-962)