ERYFOTONA ACTINICA ULTRALIGHT EMULSION- sunscreen emulsion

Eryfotona Actinica Ultralight Emulsion by

Drug Labeling and Warnings

Eryfotona Actinica Ultralight Emulsion by is a Otc medication manufactured, distributed, or labeled by ISDIN Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 11%

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

Warning

• 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 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
• During sun exposure, 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 the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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- sleeve shirts, pants, hats and sunglasses
• Children under 6 months: ask a doctor.

Other information

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

Inactive ingredients

Water, Diethylhexyl Carbonate, Dibutyl Adipate, Cyclopentasiloxane, Dicaprylyl Carbonate, Alcohol Denat., Cyclohexasiloxane, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Nylon-12, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Triethoxycaprylylsilane, Tocopheryl Acetate, Glyceryl Stearate, Fragrance, Bisabolol, Disodium EDTA, Ethylhexylglycerin, Panthenol, PEG-8, Tocopherol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid.

Questions or comments?

Call (862) 242-8129
Monday – Friday
(9 a.m. to 5 p.m. EST)
or visit www.isdin/us
USA Patent Pending

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

ISDIN
PHOTO

Eryfotona
Actinica®

Ultralight Emulsion

BROAD SPECTRUM SPF 50+

Designed for
Actinic Damage

Sunscreen with
DNA Repairsomes™
and antioxidants.

Water resistant
(40 minutes)

100% MINERAL
SUNSCREEN

3.4 FL OZ (100 mL)

INGREDIENTS AND APPEARANCE

ERYFOTONA ACTINICA ULTRALIGHT EMULSION 
sunscreen emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69494-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.1 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
Dibutyl Adipate (UNII: F4K100DXP3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Alcohol (UNII: 3K9958V90M)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
Butylene Glycol (UNII: 3XUS85K0RA)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
Nylon-12 (UNII: 446U8J075B)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
Dimethicone (UNII: 92RU3N3Y1O)
Sodium Chloride (UNII: 451W47IQ8X)
Phenoxyethanol (UNII: HIE492ZZ3T)
Disteardimonium Hectorite (UNII: X687XDK09L)
Triethoxycaprylylsilane (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LEVOMENOL (UNII: 24WE03BX2T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Ethylhexylglycerin (UNII: 147D247K3P)
Panthenol (UNII: WV9CM0O67Z)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Tocopherol (UNII: R0ZB2556P8)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Ascorbic Acid (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ANACYSTIS NIDULANS (UNII: UV4FTL6UAW)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69494-302-30	1 g in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2015
2	NDC: 69494-302-10	10 g in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/17/2015

Labeler - ISDIN Corp (079609155)

Registrant - ISDIN Corp (079609155)