EQUATE BABY SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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]

ACTIVE INGREDIENT

Active ingredients

Avobenxzone, 3%

Homosalate, 15%

Octisalate, 5%

Octocrylene, 10%

Oxybenzone, 6%

PURPOSE

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

INDICATIONS & USAGE

Uses - helps prevent sunburn - If used as directed with other sun protection measures (see Directions), decreases

the risk of skin cancerand early aging caused by the sun.

WARNINGS

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

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions  -apply liberally 15 minutes before sun

exposure  -reapply at least every 2 hours  -use a water

resistant sunscreen if swimming or sweating  -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 skin protection measures including:

-limit time in the sun, especially from 10 a.m to 2 p.m.  -wear

long-sleeved shirts, pants, hats and sunglasses

STORAGE AND HANDLING

Other information  - protect the product in this

container from excessive heat and sun

INACTIVE INGREDIENT

Inactive ingredients   water, butylene glycol, glyceryl stearate,

microcrystalline cellulose, cellulose gum,

phenoxyethanol, ethylhexylglycerin, tricontanyl

PVP, behenyl alcohol, fragrance, stearic acid,

tocopheryl acetate (vitamin E), diethylhexyl  syringylidenemalonate,

caprylic/capric triglyceride,cetyl alcohol, potassium cetyl phosphate,

disodium EDTA, reinyl palmitate,dosium hydroxide, sodium ascorbyl phosphate

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUATE   BABY SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-864
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	7.11 g  in 237 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	35.55 g  in 237 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	11.85 g  in 237 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.7 g  in 237 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	14.22 g  in 237 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
DOCOSANOL (UNII: 9G1OE216XY)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TRICAPRYLIN (UNII: 6P92858988)
CETYL ALCOHOL (UNII: 936JST6JCN)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-864-16	237 mL in 1 TUBE; Type 0: Not a Combination Product	11/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/14/2016

Labeler - Wal-Mart Stores Inc (051957769)