OP PROTECT AND RENEW FACE SPF 35- avobenzone, homosalate, octocrylene, octyl salicylate 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.

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OP-SPF35 3oz Protect Renew Face

OP Protect & Renew Face SPF 35

Active Ingredients

Avobenzone 3.0%

Active Ingredients

Homosalate 15.0%

Active Ingredients

Octocrylene 2.7%

Active Ingredients

Octyl Salicylate 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.

• Re-apply:

      • after 80 minutes of swimming or sweating

      • immediately after towel drying

      • at least every two 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

Caprylyl Methicone, Carbomer, Cetearyl Alcohol, Disodium EDTA, Ethylhexlglycerin, Glycerin, Phenoxyethanol, Palmitoyl Tripeptide-5, Potassium Cetyl Phosphate, Tapioca Starch, Tocopherol, Tocopherol Acetate, Triethanolamine, Water, Xanthan Gum

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
& Renew
face
SPF 35
3 fl oz (89ml)

PRINCIPAL DISPLAY PANEL Ocean Potion Protect & Renew face SPF 35 3 fl oz (89ml)

OP PROTECT AND RENEW FACE SPF 35 
avobenzone, homosalate, octocrylene, octyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70281-211-2485 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: 5be8134d-9a8f-4a13-bd04-8901c6707799
Set id: 8ae9eebc-426d-432e-8251-1ca45c7c0f46
Version: 2
Effective Time: 20180215
 
SolSkyn Personal Care LLC