OTC Medication Information: CVS Health SPF 30 Ultra Sheer

CVS HEALTH SPF 30 ULTRA SHEER- homosalate, octocrylene, oxybenzone, avobenzone and octisalate lotion
CVS PHARMACY

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 8.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 4.0%

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 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 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

water, silica, dimethicone, potassium cetyl phosphate, beeswax, benzyl alcohol, glyceryl stearate, PEG-100 stearate, cetyl dimethicone, caprylyl methicone, caprylyl glycol, ethyhexylglycerin, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, ethylhexyl stearate, acrylates/C12-22 alkyl methacrylate copolymer, disodium EDTA, chlorphenesin, fragrance, BHT, trideceth-6, propylene glycol

Label

CVS59034A
(click image for full-size original)

CVS57369A
(click image for full-size original)
CVS HEALTH SPF 30 ULTRA SHEER
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-028
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 80 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 40 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 40 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM POLYACRYLATE (8000 MW)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER
CAPRYLYL TRISILOXANE
ETHYLHEXYLGLYCERIN
GLYCERYL 1-STEARATE
POTASSIUM CETYL PHOSPHATE
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
PROPYLENE GLYCOL
DOCOSANOL
DIMETHICONE
CAPRYLYL GLYCOL
PEG-100 STEARATE
ETHYLHEXYL STEARATE
BENZYL ALCOHOL
XANTHAN GUM
CETYL DIMETHICONE 45
SILICON DIOXIDE
WATER
WHITE WAX
TRIDECETH-6
EDETATE DISODIUM
DIMETHICONE/PEG-10/15 CROSSPOLYMER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51316-028-09 89 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/07/2017
Labeler — CVS PHARMACY (062312574)

Revised: 01/2023 CVS PHARMACY

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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