FDA.reportPublic FDA data

SOLARA SUNCARE - CLEAN FREAK

Manufacturer
SOLARA SUNCARE, INC.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:27:39

Label at a glance#

ProductSOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTED
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

Non-Nano, Non-Coated Zinc Oxide 20%

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

0-UC_Clean Freak_Unscented_3oz0-UC_Clean Freak_Unscented_3oz

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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
95250459-30e4-45c1-b08a-993044f49109Product name220250805
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73054-101-01SOLARA SUNCARE - CLEAN FREAKSPF-30 UNSCENTED90 mL in 1 TUBELOTION9010
73054-101-11SOLARA SUNCARE - CLEAN FREAKSPF-30 UNSCENTED1 in 1 BOXLOTION110

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73054-10173054-101-01, 73054-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SHEA BUTTERK49155WL9YIACT
COCO-CAPRYLATE4828G836N6IACT
PROPANEDIOL5965N8W85TIACT
COCONUT OILQ9L0O73W7LIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SQUALANEGW89575KF9IACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
WITHANIA SOMNIFERA ROOTV038D626IFIACT
PERILLA FRUTESCENS LEAFT4L5881Y68IACT
PUNICA GRANATUM FLOWERD9B634V4GPIACT
OATZ6J799EAJKIACT
GARDENIA TAITENSIS FLOWERT0OCU8201YIACT
RUBUS IDAEUS LEAF8O2V33JG64IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
KAKADU PLUM0ZQ1D2FDLIIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETYL PALMITATE5ZA2S6B08XIACT
SORBITAN MONOPALMITATE77K6Z421KUIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENYLPROPANOL0F897O3O4MIACT
SORBITAN OLIVATEMDL271E3GRIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
FRUCTOSE6YSS42VSEVIACT
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 - CLEAN FREAK SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.0fc8fadf-69fc-40ad-b4ca-d96dd2b30f952025-12-22WarningsExact identifier
ndc (package): 73054-101-11
ndc (package): 73054-101-01
ndc (product): 73054-101
ndc11 (package): 73054010111
ndc11 (package): 73054010101
spl id: 4690e9f9-7b08-9f4e-e063-6394a90a6b94
spl set id: 0fc8fadf-69fc-40ad-b4ca-d96dd2b30f95

Reported adverse events (FAERS/openFDA)#

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