OTC Medication Information: Fruit of the Earth Sun Town City

FRUIT OF THE EARTH SUN TOWN CITY- octisalate, octocrylene, avobenzone and homosalate stick
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.

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 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 casued 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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

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

Inactive ingredients

C12-15 alkyl benzoate, paraffin, butyloctyl salicylate, synthetic wax, ozokerite, euphorbia cerifera (candelilla) wax, dimethicone, aloe barbadensis leaf juice, mineral oil, ascorbyl palmitate, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol, flavor.

Questions of comments?

Call toll free 1-800-527-7731

Fruit of the Earth Sun Town City Lip Balm SPF 30 Sunscreen Stick

0.65 OZ (17g)

NDC 62217-316-84

NDC 62217-316-85

Label
(click image for full-size original)
Label blisterFront
(click image for full-size original)
Label blisterBack
(click image for full-size original)

Fruit of the Earth Sun Town City Lip Balm SPF 30 Sunscreen Stick

0.15 OZ (4.25g)

NDC 62217-316-58

NDC 62217-316-59

Label
(click image for full-size original)
Label blister
(click image for full-size original)
FRUIT OF THE EARTH SUN TOWN CITY
lip balm spf 30 sunscreen stick stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-316
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 50 mg in 1 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE
PARAFFIN
BUTYLOCTYL SALICYLATE
CANDELILLA WAX
CERESIN
YELLOW WAX
CETYL DIMETHICONE 25
CAPRYLYL GLYCOL
CETYL ALCOHOL
MINERAL OIL
ASCORBYL PALMITATE
.ALPHA.-TOCOPHEROL ACETATE
ALOE VERA LEAF
DIMETHICONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62217-316-85 1 CONTAINER in 1 BLISTER PACK contains a CONTAINER (62217-316-84)
1 NDC:62217-316-84 17 g in 1 CONTAINER This package is contained within the BLISTER PACK (62217-316-85)
2 NDC:62217-316-59 1 CONTAINER in 1 BLISTER PACK contains a CONTAINER (62217-316-58)
2 NDC:62217-316-58 4.25 g in 1 CONTAINER This package is contained within the BLISTER PACK (62217-316-59)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/13/2020
Labeler — Fruit of the Earth, Inc. (079559467)
Registrant — Fruit of the Earth, Inc. (008193513)
Establishment
Name Address ID/FEI Operations
Fruit of the Earth, Inc. 079559467 manufacture (62217-316)

Revised: 02/2020 Fruit of the Earth, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.