OTC Medication Information: CVS Health SPF 50 Sun

CVS HEALTH SPF 50 SUN- octisalate, avobenzone, homosalate, octinoxate, octocrylene 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 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5%, Oxybenzone 5.0%

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 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

Inactive ingredients

water, C12-15 alkyl benzoate, PEG-8, adipic acid/diglycol crosspolymer, cetearyl alcohol, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, DEA-cetyl phosphate, propylene glycol, tocopheryl acetate (vitamin E), retinyl palmitate (vitamin A), sodium ascorbyl phosphate (vitamin C), arnica montana flower extract, chamomilla recutita (matricaria) flower extract, geranium maculatum extract, cucumis sativus (cucumber) fruit extract, euphrasia officinalis extract, tilia cordata flower extract, althaea officinalis root extract, yucca schidigera leaf/root/stem extract, hydrated silica, phenoxyethanol, methylparaben, propylparaben, isobutylparaben, butylparaben, ethylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, 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

SPF 50 SUN LOTION

BROAD SPECTRUM SPF 50
SUNSCREEN

UVA/UVB protection

• Hypoallergenic
• Water resistant (80 minutes)

16 FL OZ (473 mL)

Representative Image
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CVS HEALTH SPF 50 SUN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-117
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 90 mg in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 15 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)
CETYL PHOSPHATE
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
WATER
POLYETHYLENE GLYCOL 400
METHYLPARABEN
ALKYL (C12-15) BENZOATE
CETOSTEARYL ALCOHOL
PHENOXYETHANOL
ALOE VERA LEAF
SODIUM ASCORBYL PHOSPHATE
EDETATE DISODIUM ANHYDROUS
.ALPHA.-TOCOPHEROL ACETATE
ETHYLPARABEN
BUTYLPARABEN
ISOBUTYLPARABEN
PROPYLPARABEN
CUCUMBER
ARNICA MONTANA FLOWER
ALTHAEA OFFICINALIS ROOT
MATRICARIA RECUTITA
EUPHRASIA STRICTA
GERANIUM MACULATUM ROOT
TILIA CORDATA FLOWER
YUCCA SCHIDIGERA
PROPYLENE GLYCOL
HYDRATED SILICA
DIHEXADECYL PHOSPHATE
CETETH-10 PHOSPHATE
TROLAMINE
VITAMIN A PALMITATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-117-14 473 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 01/23/2017
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 (69842-117)

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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