SPOTFADE CLEAR SUNSCREEN BROAD SPECTRUM SPF 25- avobenzone, homosalate, octisalate, and octocrylene cream

SpotFade Clear Sunscreen Broad Spectrum SPF 25 by

Drug Labeling and Warnings

SpotFade Clear Sunscreen Broad Spectrum SPF 25 by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Fact Label

Active ingredient

Avobenzone – 3.0%
Homosalate – 6.0%
Octisalate – 5.0%
Octocrylene – 8%

Purpose

Sunscreen

Warnings

For external use only

When using this product

• 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 exposure.
• Reapply
  • After 40 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 avoid this risk, regularly use a sunscreen with a broad spectrum SPF or 15 or higher and other sun protection measures Including:
  • Limit time in the sun, especially from 10 a.m. to 2.p.m
  • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months Ask a doctor.

Inactive ingredients

Bisabolol, Farnesol, Isododecane, Polysilicone-11, Silica.

Questions or comments?

Within US 1-888-557-8164

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE BODY FIRM, LLC, EL SEGUNDO, CA 90245

PRINCIPAL DISPLAY PANEL - 180 mL Tube Label

BODY FIRM®

Spot Fade®

clear sunscreen
BROAD SPECTRUM SPF25

DAY

180mL | 6 FL.OZ.

INGREDIENTS AND APPEARANCE

SPOTFADE CLEAR SUNSCREEN BROAD SPECTRUM SPF 25 
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	60 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Isododecane (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LEVOMENOL (UNII: 24WE03BX2T)
Farnesol (UNII: EB41QIU6JL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-031-22	1 in 1 CARTON	12/01/2019
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70605-031-68	1 in 1 CARTON	12/01/2019
2		180 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/01/2019

Labeler - Guthy-Renker LLC (948861877)