PRO-TECT SUNSCREEN FOR PROFESSIONALS- 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.

----------

Active ingredients

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 5.0%

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 10
a.m.–2 p.m.
•wear long-sleeved shirts, pants, hats, and
sun-glasses

Other Information

• Daily usage of Pro-Tect® SPF 30+ 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.

Inactive Ingredients

Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water.


Questions or Comments

1-800-922-2883

Package label

NDC# 61619-866-08

86608_8oz_V_0005.1_06172020_Master_Test

PRO-TECT SUNSCREEN FOR PROFESSIONALS 
meradimate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61619-866
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) OXYBENZONE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LANOLIN (UNII: 7EV65EAW6H)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MINERAL OIL (UNII: T5L8T28FGP)  
TALC (UNII: 7SEV7J4R1U)  
TROLAMINE (UNII: 9O3K93S3TK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61619-866-32946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
2NDC:61619-866-0129.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
3NDC:61619-866-0259.1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
4NDC:61619-866-04118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
5NDC:61619-866-08236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/08/2016
Labeler - A-Cute Derm, Incorporated (809845803)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(61619-866)

Revised: 12/2020
Document Id: b79d7feb-288f-d13f-e053-2a95a90ab7b1
Set id: 9604b7d9-d7fc-4cce-ad11-befb7c281fff
Version: 5
Effective Time: 20201229
 
A-Cute Derm, Incorporated