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

DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen by

Drug Labeling and Warnings

DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-568
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	12.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-568-05	56 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/16/2017

Labeler - PureTek Corporation (785961046)