MEN FACE SHIELD SPF 18- homosalate, octisalate, and avobenzone lotion

MEN Face Shield SPF 18 by

Drug Labeling and Warnings

MEN Face Shield SPF 18 by is a Otc medication manufactured, distributed, or labeled by Andalou Naturals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Homosalate 12.0%	Sunscreen
Octisalate 4.0%	Sunscreen
Avobenzone 3.0%	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 or irritation develops and lasts.

• Keep out of reach of children.

Directions

• Daily, alone or under make-up.
• Apply liberally 15-30 minutes before sun exposure and as needed.
• Reapply at least every 2 hours.
• Use 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
• Children under 6 months: ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Vegetable Glycerin, Glyceryl Stearate, Stearic Acid, Sorbitan Sesquioleate, Stearyl Alcohol, Glyceryl Stearate Citrate, Cannabis Sativa (Hemp) Seed Oil1, Magnesium Ascorbyl Phosphate (Vitamin C), Cannabis Sativa (Hemp) Cell Culture Extract, Panthenol, Allantoin, Tocopherol, Sodium Hyaluronate, Phenoxyethanol, Ethylhexylglycerin, Citrus Aurantifolia (Lime) Oil1, Mentha Arvensis (Mint) Leaf Oil1, Salvia Officinalis (Sage) Leaf Extract, Limonene2, Linalool2

1 Certified Organic Ingredient

2 Component of Essential Oil

Other Information

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

Questions

Call (888) 898-6955 or visit www.Andalou.com

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Dist. by Andalou Naturals
Petaluma, CA 94954 USA

PRINCIPAL DISPLAY PANEL - 92 mL Tube Label

NEW

ANDALOU
NATURALS

MEN
SPF 18
FACE SHIELD
Protection Visage

Lightweight
Broad Spectrum Protection

CannaCell®
HEMP
STEM
CELLS

3.1 fl oz e 92 mL

INGREDIENTS AND APPEARANCE

MEN FACE SHIELD SPF 18 
homosalate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-1814
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	120 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
CANNABIS SATIVA WHOLE (UNII: B5ONF538PB)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LIME OIL (UNII: UZH29XGA8G)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
SAGE (UNII: 065C5D077J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55560-1814-1	92 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

Labeler - Andalou naturals (011472720)