FDA.reportPublic FDA data

SOLARA SUNCARE - FORTUNE TELLER

Manufacturer
SOLARA SUNCARE, INC.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:28:03

Label at a glance#

ProductSOLARA SUNCARE - FORTUNE TELLER SPF-30
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

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 protect...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22.4%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

  • 1-855-859-1600 (9am – 5pm ET)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

unit cartonunit carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73054-120-01SOLARA SUNCARE - FORTUNE TELLERSPF-3090 mL in 1 TUBELOTION905
73054-120-11SOLARA SUNCARE - FORTUNE TELLERSPF-301 in 1 BOXLOTION15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73054-12073054-120-01, 73054-120-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
XANTHAN GUMTTV12P4NEEIACT
PHYTATE SODIUM88496G1ERLIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
ENOXOLONE DIPOTASSIUMZJI2YIM6Z9IACT
BETASIZOFIRAN2X51AD1X3TIACT
COCONUT ALKANES1E5KJY107TIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCO GLUCOSIDEICS790225BIACT
POTASSIUM HYDROLYZED JOJOBA ESTERSCH428W5O62IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ARGAN OIL4V59G5UW9XIACT
RASPBERRY SEED OIL9S8867952AIACT
PEA PROTEIN7Q50F46595IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHYLLANTHUS EMBLICA FRUITYLX4CW2576IACT
SODIUM SUCCINATE HEXAHYDRATEU16QOD6C4EIACT
TOCOPHEROLR0ZB2556P8IACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
SODIUM CHLORIDE451W47IQ8XIACT
OCTYLDODECANOL461N1O614YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SHEANUT84H6HBP32LIACT
APPLEB423VGH5S9IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
MAGNESIUM OXIDE3A3U0GI71GIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLARA SUNCARE - FORTUNE TELLER SPF-30ZINC OXIDESOLARA SUNCARE, INC.f434de33-5da8-57ef-e053-2a95a90a85022025-12-22WarningsExact identifier
ndc (package): 73054-120-01
ndc (package): 73054-120-11
ndc (product): 73054-120
ndc11 (package): 73054012011
ndc11 (package): 73054012001
spl id: 4690f9ec-6458-671d-e063-6294a90a060c
spl set id: f434de33-5da8-57ef-e053-2a95a90a8502

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.