Fruit Of The Earth Sun Town City Baby Spf 50 Sunscreen Stick

Fruit Of The Earth Sun Town City Baby Spf 50 Sunscreen Stick
SPL v2
SPL
SPL Set ID c7bdd7a3-2e88-d881-e053-2a95a90a2ef9
Route
TOPICAL
Published
Effective Date 2020-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Adipic Acid/diglycol Crosspolymer (20000 Mpa.s) White Wax Alkyl (c12-15) Benzoate Caprylyl Glycol Dimethicone .alpha.-tocopherol, Dl- Neopentyl Glycol Diethylhexanoate Neopentyl Glycol Diisostearate Octyldodecyl Neopentanoate Ceresin Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-02

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

Section 51945-4

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

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

do Not Use

• on damaged or broken skin.

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

ozokerite, C12-15 alkyl benzoate, paraffin, adipic acid/diglycol crosspolymer, beeswax, octydodecyl neopentanoate, dimethicone, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearate, caprylyl glycol, tocopherol.

active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

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.


Structured Label Content

Section 51945-4 (51945-4)

Purpose

Sunscreen

uses (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

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

do Not Use (Do not use)

• on damaged or broken skin.

Other Information (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 (Inactive ingredients)

ozokerite, C12-15 alkyl benzoate, paraffin, adipic acid/diglycol crosspolymer, beeswax, octydodecyl neopentanoate, dimethicone, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearate, caprylyl glycol, tocopherol.

active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

when Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

stop Use and Ask A Doctor If (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.


Advanced Ingredient Data


Raw Label Data

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