ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX- zinc oxide oil

ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX by

Drug Labeling and Warnings

ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX by is a Otc medication manufactured, distributed, or labeled by SIBORG LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Zinc oxide 22%

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

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

Directions

• apply liberally and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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

dicaprylyl carbonate, isononyl isononanoate, coco-caprylate, C12-15 alkyl benzoate, ethylhexyl palmitate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, magnesium stearate, argania spinosa kernel oil, tocopherol, caesalpinia spinosa fruit pod extract, helianthus annuus (sunflower) sprout extract, sodium hyaluronate, tocopheryl acetate, maltodextrin, phenethyl alcohol, polyhydroxystearic acid, trihydroxystearin, mica, aqua (water), ethylhexylglycerin, sodium benzoate, iron oxides (CI 77499), titanium dioxide (CI 77891)

Package Labeling:

INGREDIENTS AND APPEARANCE

ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX 
zinc oxide oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70803-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	220 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
COCO-CAPRYLATE (UNII: 4828G836N6)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ARGAN OIL (UNII: 4V59G5UW9X)
TOCOPHEROL (UNII: R0ZB2556P8)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70803-250-01	1 in 1 BOX	03/16/2019
1		50 mL in 1 BOTTLE; 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	03/16/2019

Labeler - SIBORG LLC (102875148)