OP SPF50 AND SPORT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

OP spf50 and Sport Sunscreen by

Drug Labeling and Warnings

OP spf50 and Sport Sunscreen by is a Otc medication manufactured, distributed, or labeled by SolSkyn Personal Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

OP spf50+ Sport Sunscreen

Active ingredients:

Avobenzone 3.0%

Active ingredients:

Homosalate 15.0%

Active ingredients:

Octisalate 5.0%

Active ingredients:

Octocrylene 7.0%

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.

Re-apply:

      after 80 minutes of swimming or sweating

      immediately after towel drying

      at least every 2 hours

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 sunglasses

Children under 6 months: ask a doctor.

Inactive Ingredients:

Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Carbomer, Cholecalciferol, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Hydroxypropyl Methylcellulose, Iodopropynyl Butylcarbamate, Macrocystis Pyrifera Extract, Menthol, Phenoxyethanol, Polyester-8, Propylene Glycol, Silica, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Water

Other Information:

For use on skin only. Avoid contact with fabric.

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

Ocean Potion
Protect
& Nourish
Sport
cooling
SPF 50
8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

OP SPF50 AND SPORT SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
MENTHOL (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-217-24	227 g in 1 CONTAINER; Type 0: Not a Combination Product	09/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/15/2015

Labeler - SolSkyn Personal Care LLC (080010329)