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 ABBE Laboratories, Inc., 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

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.
Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes.
Rinse with water to remove.
Keep out of reach of children. If 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
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 10a.m.–2 p.m.
wear long-sleeved shirts, pants, hats, and sun-glasses

Other Information

protect this product from excessive heat and direct sun.

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.

Questions or Comments

Dist. by ABBE Laboratories, Inc. 1095 Route 110
Farmingdale, NY 11735 1-800-457-0990

Package Label

NDC#68605-8640-8

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: 68605-8640
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: 68605-8640-4	118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2022
2	NDC: 68605-8640-8	236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2022
3	NDC: 68605-8640-2	946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2022

Labeler - ABBE Laboratories, Inc. (781745286)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(68605-8640)