SOLARA SUNCARE - FORTUNE TELLER SPF-30- zinc oxide lotion

SOLARA SUNCARE - FORTUNE TELLER by

Drug Labeling and Warnings

SOLARA SUNCARE - FORTUNE TELLER by is a Otc medication manufactured, distributed, or labeled by SOLARA SUNCARE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Zinc Oxide 22.4%

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

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

• shake or knead before each use
• apply generously and evenly 15 minutes before sun exposure
• reapply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use asunscreen 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C13-14 Alkane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Butyrospermum Parkii (Shea) Butter, Coco-Caprylate, Propanediol, Cocos Nucifera (Coconut) Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Withania Somnifera (Ashwagandha) Root Extract, Perilla Frutescens (Mint) Leaf Extract, Punica Granatum Flower Extract, Avena Sativa (Oat) Kernel Extract, Gardenia Taitensis (Tahitian Gardenia) Flower Extract, Rubus Idaeus Leaf Extract, Potassium Sorbate, Terminalia Ferdinandiana Fruit Extract, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Cetyl Palmitate, Sorbitan Palmitate, Caprylyl Glycol, Phenylpropanol, Sorbitan Olivate, Isostearic Acid, Lecithin, Fructose

OTHER INFORMATION

• Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS

• 1-855-859-1600 (9am – 5pm ET)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLARA SUNCARE - FORTUNE TELLER  SPF-30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73054-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTATE SODIUM (UNII: 88496G1ERL)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
ENOXOLONE DIPOTASSIUM (UNII: ZJI2YIM6Z9)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
COCONUT ALKANES (UNII: 1E5KJY107T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO GLUCOSIDE (UNII: ICS790225B)
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ARGAN OIL (UNII: 4V59G5UW9X)
RASPBERRY SEED OIL (UNII: 9S8867952A)
PEA PROTEIN (UNII: 7Q50F46595)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SHEANUT (UNII: 84H6HBP32L)
APPLE (UNII: B423VGH5S9)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73054-120-11	1 in 1 BOX	07/06/2019
1	NDC: 73054-120-01	90 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 not final	part352	07/06/2019

Labeler - SOLARA SUNCARE, INC. (040998319)