FRUIT OF THE EARTH BLOCK UP BROAD SPECTRUM BABY SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene and oxybenzone lotion 
Fruit of the Earth, 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.

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Fruit of the Earth Block Up! Broad Spectrum Baby SPF 50

Active ingredients

Avobenzone 2.0%, Homosalate 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5% Oxybenzone 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 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 doctor if rash occurs.

Keep out of reach of children.

If product is 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

  • 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

  • children under 6 months: ask a doctor

Inactive ingredients

water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, propylene glycol, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), sodium ascorbyl phosphate (vitamin C), dicetyl phosphate, ceteth-10 phosphate, potassium cetyl phosphate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, hydrated silica, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, triethanolamine, fragrance (parfum)

Other information

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Questions or Comments?

Call toll free 1-800-527-7731

Principal Package Display

Fruit of the Earth

Block Up!

Broad Spectrum Baby

SPF 50

8 FL OZ (237mL)

NDC: 62217-174-05

DrugFactsPanel.jpgDrug Facts Labela.jpgLabel A Labelb.jpgLabel B

FRUIT OF THE EARTH BLOCK UP  BROAD SPECTRUM BABY SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:62217-174
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE20 mg  in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE90 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE15 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
C12-15 ALKYL BENZOATE 
POLYETHYLENE GLYCOL 400 
CETOSTEARYL ALCOHOL 
PROPYLENE 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
SODIUM ASCORBYL PHOSPHATE 
DIHEXADECYL PHOSPHATE 
CETEARETH-10 PHOSPHATE 
POTASSIUM CETYL PHOSPHATE 
PHENOXYETHANOL 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
ISOBUTYLPARABEN 
HYDRATED SILICA 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-174-05237 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/26/2014
Labeler - Fruit of the Earth, Inc. (039336490)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth008193513manufacture(62217-174)

Revised: 8/2014
 
Fruit of the Earth, Inc.