PRO-TECT SPORTS SUNSCREEN SPF 20- meradimate, octinoxate, octisalate, oxybenzone lotion 
A-Cute Derm, Incorporated

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.

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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

1-800-922-2883

Package Label

NDC# 61619-864-08

SPF 20 SUNSCREEN

PRO-TECT SPORTS SUNSCREEN SPF 20 
meradimate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61619-864
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61619-864-04118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2016
2NDC:61619-864-0259.1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2016
3NDC:61619-864-101 in 1 BOX12/22/2021
3NDC:61619-864-0629.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:61619-864-08236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2016
5NDC:61619-864-32946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/05/2016
Labeler - A-Cute Derm, Incorporated (809845803)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(61619-864)

Revised: 12/2021
Document Id: d39a1b0a-6fc0-6539-e053-2995a90a06f3
Set id: 62668419-e513-496f-a8d2-afbfc411e81c
Version: 7
Effective Time: 20211221
 
A-Cute Derm, Incorporated