Equate Baby Sunscreen: Package Insert and Label Information

EQUATE BABY SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Wal-Mart Stores Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Avobenxzone, 3%

Homosalate, 15%

Octisalate, 5%

Octocrylene, 10%

Oxybenzone, 6%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

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

For external use only

Do not use on -damaged or broken skin

When using this produc t -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 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

Other information — protect the product in this

container from excessive heat and sun

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 7.11 g in 237 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 35.55 g in 237 mL
OCTISALATE (OCTISALATE) OCTISALATE 11.85 g in 237 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 23.7 g in 237 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 14.22 g in 237 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BUTYLENE GLYCOL
GLYCERYL MONOSTEARATE
MICROCRYSTALLINE CELLULOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
TRICONTANYL POVIDONE
DOCOSANOL
STEARIC ACID
.ALPHA.-TOCOPHEROL ACETATE
DIETHYLHEXYL SYRINGYLIDENEMALONATE
TRICAPRYLIN
CETYL ALCOHOL
POTASSIUM CETYL PHOSPHATE
EDETATE DISODIUM ANHYDROUS
VITAMIN A PALMITATE
SODIUM HYDROXIDE
SODIUM ASCORBYL PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-864-16 237 mL in 1 TUBE None
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)

Revised: 01/2020 Wal-Mart Stores Inc

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