PRO-TECT SPORTS SUNSCREEN SPF 20- meradimate, octinoxate, octisalate, oxybenzone lotion

Pro-Tect Sports Sunscreen SPF 20 by

Drug Labeling and Warnings

Pro-Tect Sports Sunscreen SPF 20 by is a Otc medication manufactured, distributed, or labeled by A-Cute Derm, Incorporated, Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

Purpose

Sunscreen

Uses

Pro-Tect® SPF 20+ Broad-Spectrum UVA & UVB protection. Helps prevent sunburn. Retains a SPF of 20+ after 80 minutes of activity in water or 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 or their related compounds.

KEEP OUT OF REACH OF CHILDREN

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, 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 SPF20+ may help reduce the chance of premature aging of the skin due to

overexposure to the sun. This product provides more than 20 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

Questions or Comments

A-Cute Derm, Inc.

1810 Cravens Road

Stafford, TX 77477

800.922.2883

M-F 8:30am-5:30pm

info@a-cutederm.com

www.a-cutederm.com

Principal Display Panel

Pro-Spectrum ProcessTM

Broad-Spectrum UVA/UVB

Sunscreen

Greaseless & Very

Water-Resistant

Fortified with Aloe

& Vitamin E

Fragrance Free

Non-Comedogenic

NDC# 61619-864-04

4.0 FL OZ (118.3 ml)

INGREDIENTS AND APPEARANCE

PRO-TECT SPORTS SUNSCREEN SPF 20 
meradimate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61619-864
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61619-864-04	118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2016
2	NDC: 61619-864-02	59.1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2016
3	NDC: 61619-864-06	29.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2016
4	NDC: 61619-864-08	236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2016
5	NDC: 61619-864-32	946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/05/2016

Labeler - A-Cute Derm, Incorporated (809845803)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(61619-864)