PRO-TECT EVERYDAY SUNSCREEN SPF 15- octinoxate, octisalate, padimate o lotion

PRO-TECT EVERYDAY SUNSCREEN SPF 15 by

Drug Labeling and Warnings

PRO-TECT EVERYDAY SUNSCREEN SPF 15 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]

DRUG FACTS

Pro-Tect® SPF 15+ Sunscreen Broad-Spectrum UVA/UVB Protection & Moisturizing Lotion

Active Ingredients

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

Oxybenzone.........................................................2.0%

Padimate O...........................................................5.0%

Purpose

Sunscreen

Uses

Pro-Tect® SPF 15+ Broad-Spectrum UVA & UVB protection. Helps prevent sunburn. Retains a SPF

of 15+ 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, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked),

Cetyl Alcohol, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate,

Iodopropynyl Butylcarbamate, Trolamine, Water.

Other Information

Daily usage of Pro-Tect SPF15+ may help reduce the chance of premature aging of the skin due to

overexposure to the sun. This product provides more than 15 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

Bio-Medical & Pharm. Mfg. Corp.

4311 South Dr.

Houston, TX 77053-4820

281-835-8051

M-F 8AM-5PM

www.bio-medicalmanufacturing.com

Principal Display Panel

Pro-Tect

SPF 15

Sunscreen

29.6 grams

NDC: 61619-868-07

INGREDIENTS AND APPEARANCE

PRO-TECT EVERYDAY SUNSCREEN SPF 15 
octinoxate, octisalate, padimate o lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61619-868
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	50 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61619-868-07	29.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/03/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/03/2015

Labeler - A-Cute Derm, Incorporated (809845803)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(61619-868)