ULTRA SHEER DAILY DEFENSE FACIAL SPF 18- homosalate, octisalate, and avobenzone lotion

ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 by

Drug Labeling and Warnings

ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 by is a Otc medication manufactured, distributed, or labeled by Andalou naturals, Sun Deep Inc. 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, Helianthus Annuus (Sunflower) Seed Oil1, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Panthenol, Allantoin, Tocopherol, Sodium Hyaluronate, Resveratrol, Ubiquinone (CoQ10), Magnesium Ascorbyl Phosphate (Vitamin C), Dipotassium Glycyrrhizinate (Licorice) Root Extract1, Laminaria Digitata (Kelp) Extract, Chamomilla Recutita (Chamomile) Flower Extract1, Calendula Officinalis Flower Extract1, Rosa Canina (Rosehip) Fruit Oil1, Camellia Sinensis (White Tea) Leaf Extract12, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil1

1 Certified Organic

2 Fair Trade Ingredient

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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Distributed by Andalou Naturals,
Petaluma, CA 94954 USA

PRINCIPAL DISPLAY PANEL - 80 mL Tube Box

ANDALOU
NATURALS

Ultra Sheer
DAILY DEFENSE

Facial Lotion
SPF 18

with Resveratrol Q10
Youthful Vitality

Broad Spectrum Protection

FRUIT
STEM
CELL
SCIENCE®

AGE DEFYING

2.7 fl oz / 80 mL

INGREDIENTS AND APPEARANCE

ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 
homosalate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-3331
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)
SUNFLOWER OIL (UNII: 3W1JG795YI)
APPLE (UNII: B423VGH5S9)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
RESVERATROL (UNII: Q369O8926L)
UBIDECARENONE (UNII: EJ27X76M46)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
LICORICE (UNII: 61ZBX54883)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
WHITE TEA (UNII: O0M3396E09)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TANGERINE (UNII: KH3E3096OO)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55560-3331-1	1 in 1 BOX	01/01/2021
1		80 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2021

Labeler - Andalou naturals (011472720)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc		189788201	MANUFACTURE(55560-3331)