ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30- zinc oxide lotion

ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 by

Drug Labeling and Warnings

ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 by is a Otc medication manufactured, distributed, or labeled by Andalou naturals, Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredient

Zinc Oxide 15.7%
Purpose

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 occurs.
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor.
- Use daily or alone under makeup.
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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
Other Information
- Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Water/Aqua/Eau, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Tetradecane, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Ectoin, Arachidyl Alcohol, Caprylyl Glycol, Diheptyl Succinate, Coco-Glucoside, Xanthan Gum, Calcium Sodium Borosilicate, Helianthus Annuus (Sunflower) Seed Oil, Behenyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Bisabolol1, Citric Acid, Arachidyl Glucoside, Sodium Gluconate, Glycerin, Caprylhydroxamic Acid, Tocopherol (Vitamin E), Beta-Sitosterol, Squalene, Aloe Barbadensis (Aloe Vera) Leaf Juice1, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Isomalt, Beta Vulgaris (Beet) Root Extract, Fructooligosaccharides, Malus Domestica (Apple) Fruit Cell Culture Extract, Aronia Melanocarpa (Black Chokeberry) Fruit Extract1, Camellia Sinensis (Tea) Leaf Extract1, Euterpe Oleracea (Açai) Fruit Extract1, Lycium Barbarum (Goji) Fruit Extract1, Spirulina Maxima Extract, sr-Hydrozoan Polypeptide-1, Soy Lecithin, Sodium Benzoate, Vitis Vinifera (Grape) Fruit Cell Extract, Natural Fragrance, Linalool 2 , Citronellol 2 , Hexyl Cinnamal 2 , Limonene 2

1 Certified Organic,

2 Component of Natural Fragrance.

Questions or Comments?

Call (415) 446-9470.

SPL UNCLASSIFIED SECTION

Dist. by Andalou Naturals,
Petaluma, CA 94954.

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

MINERAL
SUNSCREEN

ANDALOU
NATURALS

RECOMMENDED
Skin
Cancer
Foundation
DAILY USE

DAILY SHADE +
Blue Light Defense
Facial Lotion
Hyaluronic Acid + Ectoin

SPF 30
Broad Spectrum SPF 30

FRUIT
STEM
CELL
SCIENCE®

DEEP
HYDRATION

2.7 fl oz / 80 mL

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

INGREDIENTS AND APPEARANCE

ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-2201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	157 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TETRADECANE (UNII: 03LY784Y58)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ECTOINE (UNII: 7GXZ3858RY)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
COCO-GLUCOSIDE (UNII: ICS790225B)
XANTHAN GUM (UNII: TTV12P4NEE)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DOCOSANOL (UNII: 9G1OE216XY)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
LEVOMENOL (UNII: 24WE03BX2T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SODIUM GLUCONATE (UNII: R6Q3791S76)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TOCOPHEROL (UNII: R0ZB2556P8)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
SQUALENE (UNII: 7QWM220FJH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ISOMALT (UNII: S870P55O2W)
BEET (UNII: N487KM8COK)
SACCHARUM OFFICINARUM STEM FRUCTOOLIGOSACCHARIDES (UNII: 8LLD82AE3S)
APPLE (UNII: B423VGH5S9)
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
TEA LEAF (UNII: GH42T47V24)
ACAI (UNII: 46AM2VJ0AW)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
PODOCORYNA CARNEA FIBRILLAR COLLAGEN (UNII: L2CJP3X029)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
SODIUM BENZOATE (UNII: OJ245FE5EU)
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE (UNII: ZLW3M94UYA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 55560-2201-1	1 in 1 CARTON	01/12/2022
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 DRUG	M020	01/12/2022

Labeler - Andalou naturals (011472720)

Name	Address	ID/FEI	Business Operations
Establishment
Bell International Laboratories		967781555	MANUFACTURE(55560-2201)