ULTRA SHEER DAILY DEFENSE FACIAL SPF 18- octisalate, octocrylene, 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredients Purpose

Octisalate 5.0% Sunscreen

Octocrylene 5.0% Sunscreen

Avobenzone 2.5% 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.
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, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil1, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Dimethicone, Lecithin, Tocopherol, Magnesium Ascorbyl Phosphate (Vitamin C), Resveratrol, Ubiquinone (CoQ10), Panthenol, Allantoin, Dipotassium Glycyrrhizinate (Licorice) Root Extract1, Laminaria Digitata (Kelp) Extract, Curcuma Longa (Turmeric) Root Extract1, Epilobium Angustifolium (Willow Herb) Extract, Chamomilla Recutita (Chamomile) Flower Extract1, Calendula Officinalis Flower Extract1, Sodium Hyaluronate, Rosa Canina (Rosehip) Fruit Oil1, Camellia Sinensis (White Tea) Leaf Extract1 2, Aspalathus Linearis (Rooibos) Extract1 2, Hibiscus Sabdariffa Flower Extract1 2, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil1

1 Certified Organic

2 Fair Trade Ingredients

Active Ingredients	Purpose
Octisalate 5.0%	Sunscreen
Octocrylene 5.0%	Sunscreen
Avobenzone 2.5%	Sunscreen

Other Information

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

Questions

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

SPL UNCLASSIFIED SECTION

Dist. by Andalou Naturals
Novato, CA 94945 USA

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

NEW LOOK

ANDALOU
NATURALS

NON
GMO

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 e 80 mL

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-1811
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
APPLE (UNII: B423VGH5S9)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
ACAI (UNII: 46AM2VJ0AW)
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
DIMETHICONE (UNII: 92RU3N3Y1O)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
RESVERATROL (UNII: Q369O8926L)
UBIDECARENONE (UNII: EJ27X76M46)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
LICORICE (UNII: 61ZBX54883)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
TURMERIC (UNII: 856YO1Z64F)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
WHITE TEA (UNII: O0M3396E09)
ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)
ORANGE OIL (UNII: AKN3KSD11B)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 55560-1811-1	1 in 1 CARTON	12/10/2012
1		80 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/01/2011

Labeler - Andalou naturals (011472720)