OTC Medication Information: Surface Sun Sheer Touch SPF 50 Sunscreen

SURFACE SUN SHEER TOUCH SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, oxybenzone and octocrylene spray
Surface Products Corp

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.

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only.

Flammable: do not use near heat, flame, or while smoking. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Keep away from face to avoid breathing it. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F. 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

Spray liberally and evenly by hand 15 minutes before sun exposure.

Reapply after:

80 minutes of sweating or swimming
immediately after towel drying
at least every 2 hours

Hold can 4-6 inches from the skin to apply. Do not spray directly into your face. Spray on hands an then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.

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-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: ask a doctor.

Inactive Ingredients

Acrylates/Octylacrylamide Crosspolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin.

Label

Surface Sun Sheer Touch SPF 50
(click image for full-size original)

SURFACE SUN SHEER TOUCH SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72344-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 15 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 6 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
DIETHYLHEXYL SYRINGYLIDENEMALONATE
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72344-003-06 170 mL in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/14/2018
Labeler — Surface Products Corp (010777036)
Registrant — CGI Packaging, LLC (080691099)
Establishment
Name Address ID/FEI Operations
CGI Packaging, LLC 080691099 manufacture (72344-003)

Revised: 05/2018 Surface Products Corp

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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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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