OTC Medication Information: CVS Health SPF 30 Ultra Sheer

CVS HEALTH SPF 30 ULTRA SHEER- octinoxate, 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 2.0%, Homosalate 7.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

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.

​Keep out of reach of children. ​If product is swallowed, get medical help or contact a Poison Control Center right away.

​Stop use and ask a doctor if rash occurs.​

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

Inactive ingredients

water, silica, adipic acid/diethylene glycol/glycerin crosspolymer, VP/hexadecene copolymer, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, avena sativa (oat) kernel extract, squalane, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, BHT, cetyl dimethicone, bisabolol, dipotassium glycyrrhizate, glyceryl stearate, PEG-100 stearate, polysorbate 60, tetrasodium EDTA, butylene glycol, trimethylsiloxysilicate, xanthan gum, benzyl alcohol, isopropylparaben, isobutylparaben, butylparaben, phenoxyethanol, fragrance

Other information

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

Questions or comments?

Call toll free 1-800-SHOP-CVS

CVS HEALTH

ULTRA SHEER SPF 30 LOTION

BROAD SPECTRUM SPF 30 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 30 ULTRA SHEER
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-118
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 70 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL ACETATE
CETYL DIMETHICONE 25
DIMETHICONE
ISOPROPYLPARABEN
ISOBUTYLPARABEN
ASCORBYL PALMITATE
GLYCYRRHIZINATE DIPOTASSIUM
PHENOXYETHANOL
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
EDETATE SODIUM
VITAMIN A PALMITATE
GLYCERYL 1-STEARATE
SQUALANE
BUTYLATED HYDROXYTOLUENE
XANTHAN GUM
POLYSORBATE 60
BUTYLPARABEN
WATER
OAT
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
GLYCERIN
BENZYL ALCOHOL
BUTYLENE GLYCOL
LEVOMENOL
SILICON DIOXIDE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
PEG-100 STEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-118-09 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 01/24/2017
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 (69842-118)

Revised: 01/2017 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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