SOLARA SUNCARE - FORTUNE TELLER SPF-30- zinc oxide lotion 
SOLARA SUNCARE, INC.

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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SOLARA SUNCARE - FORTUNE TELLER BRIGHTENING SUNSCREEN SERUM (73054-120)

ACTIVE INGREDIENTS

Zinc Oxide 22.4%

PURPOSE

Sunscreen

USES

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 product is swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

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

QUESTIONS OR COMMENTS

unit carton

SOLARA SUNCARE - FORTUNE TELLER  SPF-30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73054-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73054-120-111 in 1 BOX07/06/2019
1NDC:73054-120-0190 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/06/2019
Labeler - SOLARA SUNCARE, INC. (040998319)

Revised: 2/2023
Document Id: f43854ac-3d49-5979-e053-2995a90a1a2e
Set id: f434de33-5da8-57ef-e053-2a95a90a8502
Version: 2
Effective Time: 20230208
 
SOLARA SUNCARE, INC.