OTC Medication Information: CVS Health SPF 15 Clear Hawaii Compliant

CVS HEALTH SPF 15 CLEAR HAWAII COMPLIANT- avobenzone, homosalate and octisalate spray
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 10.0%, Octisalate 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

FLAMMABLE:

• do not use near heat, flame or while smoking
• avoid long term storage above 104°F (40°C)

​Do not use

  • ​​on damaged or broken skin

When using this product • keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

​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

•spray liberally and spread evenly by hand15 minutes before sun exposure
• hold can 4-6 inches away from the skin to apply
• do not spray into face. Spray into hands, then apply to face.

• do not apply in windy conditions

• use in well-ventilated areas
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

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

alcohol denat., tridecyl salicylate, acrylates/octylacrylamide copolymer, glycerin, tocopherol (vitamin E), aloe barbadensis leaf extract, mineral oil, cocos nucifera (coconut) oil, fragrance.

CVS59888D2
(click image for full-size original)

CVS30574A
(click image for full-size original)
CVS HEALTH SPF 15 CLEAR HAWAII COMPLIANT
avobenzone, homosalate, octisalate, oxybenzone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-452
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
GLYCERIN
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL, DL-
COCONUT OIL
MINERAL OIL
TRIDECYL SALICYLATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-452-37 156 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/20/2018
Labeler — CVS Pharmacy (062312574)

Revised: 07/2021 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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