DERMACINRX SKIN MOISTURIZING ULTRA SPF 50 SUNSCREEN- avobenzone, octinoxate, octisalate, titanium dioxide lotion 
PureTek Corporation

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.

----------

Dermacin ®Rx Skin Moisturizing Ultra SPF 50 Sunscreen Lotion

(avobenzone, octinoxate, octisalate, titanium dioxide)

Active ingredients (% w/w)

Avobenzone 2.5%

Octinoxate 3%

Octisalate 3%

Titanium Dioxide 1.25%

Purposes

Sunscreen (Avobenzone 2.5%)
Sunscreen (Octinoxate 3%)
Sunscreen (Octisalate 3%)
Sunscreen (Titanium Dioxide 1.25%) 

Uses

■ Helps prevent sunburn.

■ If used as a directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.   

Warnings

For external use only

Do not use

■ on damaged or broken skin

When using this product

■ keep out of eyes

■ Rinse with water to remove

Stop use and ask a doctor if

■ rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Apply liberally 15 minutes before sun exposure ■ Use a water-resistant sunscreen if swimming or sweating or immediately after towel drying   
■ Reaply: ■ 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 the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses. ■ Children under six months of age: Ask a doctor.

Inactive ingredients

Water, Emulsifying Wax, Shea butter, Stearic Acid, Ethylhexyl Palmitate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Sunflower Seed Oil, Isopropyl Isostearate, Vitamin E, Potassium Sorbate, Xanthan Gum, Sodium Benzoate.

Other information

■ Protect this product from excessive heat and direct sun

Questions?

1.800.611.4270 

Dermacin ®Rx Skin Moisturizing Ultra SPF 50 Sunscreen Lotion (Label)

DISTRIBUTED BY:

PureTek Corporation
San Fernando, CA 91340

image description

DERMACINRX SKIN MOISTURIZING ULTRA SPF 50 SUNSCREEN 
avobenzone, octinoxate, octisalate, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-568
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-568-0556 mL in 1 BOTTLE; Type 0: Not a Combination Product02/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/16/2017
Labeler - PureTek Corporation (785961046)

Revised: 1/2023
Document Id: f20534c0-4cbf-31f7-e053-2995a90a6879
Set id: 86eb06cc-d63f-4500-a52e-14ef99a56532
Version: 4
Effective Time: 20230111
 
PureTek Corporation