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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Homosalate 12.0%	Sunscreen
Octyl Salicylate 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Daily, alone or under make-up.
• Apply liberally 15 minutes before sun exposure and as needed.
• Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
• Use water resistant sunscreen if swimming or sweating.
• Children under 6 months: ask a doctor.
• 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.

Inactive Ingredients

Aqua/Water/Eau, Glycerin, Aloe Barbadendis (Aloe Vera) Leaf Juice1, Sorbitan Sesquioleate, Glyceryl Stearate, Natural Fragrance, Stearyl Alcohol, Phenoxyethanol, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Glyceryl Stearate Citrate, Malus Domestica (Apple) Fruit Cell Culture, Lecithin, Xanthan Gum, Carbomer, Panthenol (Pro-Vitamin B5), Malus Domestica (Apple) Fruit Cell Culture Extract, Tocopherol (Vitamin E), Ethylhexylglycerin, Allantoin, Vitis Vinifera (Grape) Callus Culture Extract, 1,2-Hexanediol, Sodium Hyaluronate, Euterpe Oleracea (Açai) Fruit Extract1, Aronia Melanocarpa (Black Chokeberry) Fruit Extract1, Lycium Barbarum (Goji) Fruit Extract1, Camellia Sinensis (White Tea) Leaf Extract1, Pichia/Resveratrol Ferment Extract, Potassium Sorbate, Magnesium Ascorbyl Phosphate (Vitamin C), Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Alcohol1, Aspalathus Linearis (Rooibos) Leaf Extract1, Hibiscus Sabdariffa (Roselle) Flower Extract1, Calendula Officinalis Flower Extract1, Ubiquinone (Co-Enzyme Q10).

1 Certified Organic 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

SPL UNCLASSIFIED SECTION

Dist. By: Andalou Naturals
165 1st St., Petaluma, CA 94952 USA

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

SUNSCREEN

ANDALOU
NATURALS

Ultra Sheer
DAILY DEFENSE

Facial Lotion
SPF 18

with Resveratrol + CoQ10
+ Hyaluronic Acid

Broad Spectrum SPF 18

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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
APPLE (UNII: B423VGH5S9)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALLANTOIN (UNII: 344S277G0Z)
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE (UNII: ZLW3M94UYA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ACAI (UNII: 46AM2VJ0AW)
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
TEA LEAF (UNII: GH42T47V24)
RESVERATROL (UNII: Q369O8926L)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ISOMALT (UNII: S870P55O2W)
ALCOHOL (UNII: 3K9958V90M)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
UBIDECARENONE (UNII: EJ27X76M46)

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 DRUG	M020	01/01/2021

Labeler - Andalou naturals (011472720)

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