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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ultra Sheer Daily Defense Facial Lotion SPF 18

Drug Facts

Active IngredientsPurpose
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 Extract12, Aspalathus Linearis (Rooibos) Extract12, Hibiscus Sabdariffa Flower Extract12, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil1

1
Certified Organic
2
Fair Trade Ingredients

Other Information

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

Questions

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

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
ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 
octisalate, octocrylene, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-1811
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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, COLD PRESSED (UNII: AKN3KSD11B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55560-1811-11 in 1 CARTON12/10/201212/30/2021
180 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/01/201112/30/2021
Labeler - Andalou naturals (011472720)

Revised: 7/2019
Document Id: 15ca1bc1-d047-495e-94d4-92f8fa2b3d80
Set id: 58fd7b0c-4b4b-4705-b325-49fbfbac889a
Version: 3
Effective Time: 20190715
 
Andalou naturals