OTC Medication Information: CVS Health SPF 45 Ultra Sheer

CVS HEALTH SPF 45 ULTRA SHEER- octocrylene, octisalate, homosalate, avobenzone and oxybenzone 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 10.0%, Octisalate 5.0%, Octocrylene 2.8%, 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
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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: ask a doctor

Other information

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

Inactive ingredients

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

Questions or comments?

Call toll free 1-800-SHOP-CVS

CVS Health

ULTRA SHEER LOTION

BROAD SPECTRUM SPF 45 SUNSCREEN

UVA/UVB protection

• Light, clean & oil free

• Won’t clog pores

• Water resistant (80 minutes)

• Dermatologist tested

COMPARE TO NEUTROGENA

ULTRA SHEER® DRY-TOUCH*

3.0 FL OZ (89 mL)

Representative Image
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CVS HEALTH SPF 45 ULTRA SHEER
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-122
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 28 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 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
PROPYLENE GLYCOL
CAPRYLYL TRISILOXANE
EDETATE DISODIUM ANHYDROUS
METHYLPARABEN
TRIDECETH-6
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
IODOPROPYNYL BUTYLCARBAMATE
ETHYLPARABEN
XANTHAN GUM
ETHYLHEXYL STEARATE
BUTYLATED HYDROXYTOLUENE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
DIMETHICONE
WATER
BUTYLOCTYL SALICYLATE
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER
SILICON DIOXIDE
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
DOCOSANOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
SODIUM POLYACRYLATE (8000 MW)
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-122-09 89 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2017
Labeler — CVS Pharmacy (062312574)
Registrant — Fruit of the Earth, Inc. (079559467)
Establishment
Name Address ID/FEI Operations
Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture (69842-122)

Revised: 02/2017 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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