EQUATE SUNSCREEN BABY BROAD SPECTRUM SPF 50- avobenzone homosalate octocrylene lotion

EQUATE Sunscreen BABY Broad Spectrum SPF 50 by

Drug Labeling and Warnings

EQUATE Sunscreen BABY 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

Avobenzone 3.0%
Homosalate 10.0%
Octocrylene 6.0%

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 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, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate crosspolymer, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone

PRINCIPAL DISPLAY PANEL

EQUATE Sunscreen BABY Broad Spectrum SPF 50 Lotion

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN BABY BROAD SPECTRUM SPF 50 
avobenzone homosalate octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-969
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOMER 934 (UNII: Z135WT9208)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
COCO GLUCOSIDE (UNII: ICS790225B)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-969-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/29/2019

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(49035-969)