OTC Medication Information: Harmon Face Values Ultra Light Dry to the Touch Suncreen SPF 55

HARMON FACE VALUES ULTRA LIGHT DRY TO THE TOUCH SUNCREEN SPF 55- octocrylene, octisalate, homosalate, avobenzone and oxybenzone lotion
HARMON STORES, 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 3.0%, Octocrylene 7.0%, Oxybenzone 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 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

  • children under 6 months: 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

Inactive ingredients

water, butyloctyl salicylate, styrene/acrylates copolymer, silica, VP/hexadecene copolymer, polysilicone-15, behenyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ethylhexylglycerin, caprylyl methicone, phenoxyethanol, ethylhexyl stearate, BHT, trideceth-6, trimethylsiloxysilicate, sodium polyacrylate, xanthan gum, disodium EDTA, methylparaben, iodopropynyl butylcarbamate, ethylparaben, propylparaben, propylene glycol, fragrance

Other information

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

Harmon Face Values Ultra Light Dry to the Touch Suncreen Lotion SPF 55

3.0 FL OZ (89 mL)

42887A1
(click image for full-size original)
HARMON FACE VALUES ULTRA LIGHT DRY TO THE TOUCH SUNCREEN SPF 55
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-078
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 70 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 30 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
METHYLPARABEN
TRIDECETH-6
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)
IODOPROPYNYL BUTYLCARBAMATE
ETHYLPARABEN
XANTHAN GUM
ETHYLHEXYL STEARATE
BUTYLATED HYDROXYTOLUENE
PHENOXYETHANOL
CAPRYLYL TRISILOXANE
ETHYLHEXYLGLYCERIN
DIMETHICONE
WATER
BUTYLOCTYL SALICYLATE
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER
SILICON DIOXIDE
POLYSILICONE-15
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
DOCOSANOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
SODIUM POLYACRYLATE (8000 MW)
PROPYLPARABEN
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63940-078-09 89 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/23/2012
Labeler — HARMON STORES, INC. (804085293)

Revised: 07/2021 HARMON STORES, 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.

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.

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