OP SPF 70 ANTI AGING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
SolSkyn Personal Care LLC

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.

----------

OP Protect Nourish Sunscreen Ltn SPF 70

OP SPF 70 Anti Aging Sunscreen 

Active ingredients

Avobenzone 2.0%

Active ingredients

Homosalate 15.0%

Active ingredients

Octisalate 5.0%

Active ingredients

Octocrylene 2.0%

Active ingredients

Oxybenzone 6.0%

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, C12-15 Alkyl Benzoate, Carbomer, Cholecalciferol, Dimethyl Capramide, DisodiumEDTA, Fragrance, Iodopropynyl Butylcarbamate, Macrocystis Pyrifera (Kelp) Extract, Olea Europaea (Olive) Fruit Oil, Peg-40 Hydrogenated Castor Oil, Phenoxyethanol, Polyester-8, PropyleneGlycol, Retinyl Palmitate, 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
Vitamin D3
SPF 70
8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL Ocean Potion Protect & Nourish Vitamin D3 SPF 70 8 fl oz (237 mL)

OP SPF 70 ANTI AGING SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70281-220-24227 g in 1 CONTAINER; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/15/2015
Labeler - SolSkyn Personal Care LLC (080010329)

Revised: 2/2018
Document Id: c4cefe34-f102-4709-94a0-e60deb43d824
Set id: e4596b72-9ffe-420f-8444-ce6ebc57d646
Version: 2
Effective Time: 20180215
 
SolSkyn Personal Care LLC