Pro-Tect SPF 30 Sunscreen description, usages, side effects, indications, overdosage, supplying and lots more!

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Pro-Tect SPF 30 Sunscreen

A-Cute Derm, Incorporated

Pro-Tect SPF 30 Sunscreen


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Pro-Tect® SPF 30+ Sunscreen Broad-Spectrum UVA/UVB Protection & Moisturizing Lotion

Active Ingredients

Meradimate..........................................................5.0%

Octinoxate...........................................................7.5%

Octisalate.............................................................5.0%

Oxybenzone.........................................................3.0%

Purpose

Sunscreen

Pro-Tect SPF 30 Sunscreen Uses

•Pro-Tect® SPF 30+ Broad-Spectrum UVA & UVB protection. •Helps prevent sunburn. •Retains a SPF of 30+ after 80 minutes of activity in water of perspiring. •Provides high protection against sunburn and tanning. •For skin highly sensitive to sunburn.

Warnings

•External use only. •When using this product, keep out of eyes. •Rinse with water to remove. •Stop use and ask a doctor if rash or irritation develops and lasts. •Do not use if sensitive to any of the ingredients of their related compounds.

​KEEP OUT OF REACH OF CHILDREN

Directions

•Apply liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed. •Children under 6 months of age: ask a doctor.

Inactive Ingredients

•Aloe Vera Leaf, Benzyl Alcohol, C18-C36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Stearic Acid, Talc, Trolamine, Water.

Other Information

•Daily usage of Pro-Tect SPF30+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. •This product provides more than 30 times your natural protection against sunburn. •Very Water Resistant UVA & UVB Broad-Spectrum Protection. •This product may stain light colored fabrics if washed with bleach. Wash clothing without bleach to remove safely.

Questions or Comments

A-Cute Derm Inc.
1810 Cravens Road Stafford, Texas 77477-3534
800.922.2883 M-F 8:30am-5:30pm
info@a-cutederm.com
www.a-cutederm.com

Image of 32 oz. Label NDC# 61619-866-32

ProtectSPF3032oz.jpgPro-Tect SPF 30 Sunscreen

Pro-Tect SPF 30 Sunscreen

Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61619-866
Route of Administration CUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MERADIMATE Meradimate 50 mg
OCTINOXATE OCTINOXATE 75 mg
OCTISALATE OCTISALATE 50 mg
OXYBENZONE OXYBENZONE 30 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
BENZYL ALCOHOL
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
CETYL DIMETHICONE 45
DIAZOLIDINYL UREA
DIETHANOLAMINE CETYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE, DL-
IODOPROPYNYL BUTYLCARBAMATE
STEARIC ACID
talc
TROLAMINE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61619-866-06 29.6 in 1 BOTTLE, PLASTIC
2 NDC:61619-866-02 59.2 in 1 BOTTLE, PLASTIC
3 NDC:61619-866-04 118.3 in 1 BOTTLE, PLASTIC
4 NDC:61619-866-08 236.6 in 1 BOTTLE, PLASTIC
5 NDC:61619-866-32 946.4 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 1980-11-01


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