Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

DERMECTIN SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide cream 
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.

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Drug Facts

Active ingredient

Titanium dioxide 7.1%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• moderate protection against sunburn

Warnings

For external use only

Do not use

• on broken or damaged skin
  

When using this product

• keep out of eyes
• rinse with water to remove

Stop use and ask a doctor if

• skin rash occurs
  

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Central right away.

Directions

• for sunscreen use
• apply liberally and evenly 15 minutes before sun exposure
• apply to all skin exposed to the sun
• reapply
• after 40 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 of age: Ask a doctor

other information

• protect the product in this container from excessive heat and direct sun
  

Inactive ingredients

purified water, cyclopentasiloxane, octyldodecyl neopentanoate, pentylene glycol, butylene glycol, stearic acid, dicaprylyl carbonate, polyglyceryl-3 polydimethylsiloxyethyl dimethicone, helianthus annuus (sunflower) seed oil unsaponifiables, butyrospermum parkii (shea butter), dimethicone crosspolymer, dimethicone, glyceryl stearate, PEG-100 stearate, C20-22 alkyl phosphate, stearyl dimethicone, C20-22 alcohols, magnesium aluminum silicate, dimethicone/PEG-10/15 crosspolymer, hydrogenated lecithin, cetearyl alcohol, polysorbate 60, triethanolamine, camellia sinensis leaf extract (white tea and oolong tea), camellia oleifera (green tea) seed extract, chlorphenesin,  panthenol, xanthan gum, sodium ascorbyl phosphate, tocopheryl acetate, tetrahexyldecyl ascorbate, dipotassium glycyrrhizate, aluminum hydroxide.

Questions or Comments:

877-921-7873

Carton

DERMECTIN SUNSCREEN  BROAD SPECTRUM SPF 30
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-942
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	71 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
CAMELLIA OLEIFERA SEED (UNII: 59ED29FM2J)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 STEARATE (UNII: YD01N1999R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-942-08	1 in 1 CARTON	07/12/2011	03/28/2019
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/12/2011	03/28/2019

Labeler - PureTek Corporation (785961046)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	manufacture(59088-942)

Revised: 3/2019

Document Id: 19549360-25e5-48dc-a262-414ec49245d2

34390-5

Set id: 1c437153-e9d2-4fce-8506-35da727eb9e3

Version: 2

Effective Time: 20190328