DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen: Package Insert and Label Information

DERMACINRX SKIN MOISTURIZING ULTRA SPF 50 SUNSCREEN- avobenzone, octinoxate, octisalate and 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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 25 mg in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 30 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 30 mg in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 12.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
POLAWAX POLYSORBATE
SHEA BUTTER
STEARIC ACID
ETHYLHEXYL PALMITATE
PHENOXYETHANOL
BENZOIC ACID
DEHYDROACETIC ACID
SUNFLOWER OIL
ISOPROPYL ISOSTEARATE
.ALPHA.-TOCOPHEROL
POTASSIUM SORBATE
XANTHAN GUM
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-568-05 56 mL in 1 BOTTLE None
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)

Revised: 01/2021 PureTek Corporation

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