SOLARA SUNCARE - CLEAN FREAK  SPF-30 UNSCENTED- 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 - CLEAN FREAK SPF-30 UNSCENTED (73054-101)

ACTIVE INGREDIENTS

Non-Nano, Non-Coated Zinc Oxide 20%

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

0-UC_Clean Freak_Unscented_3oz

SOLARA SUNCARE - CLEAN FREAK   SPF-30 UNSCENTED
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73054-101
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
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
PROPANEDIOL (UNII: 5965N8W85T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
SQUALANE (UNII: GW89575KF9)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)  
OAT (UNII: Z6J799EAJK)  
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
FRUCTOSE (UNII: 6YSS42VSEV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73054-101-111 in 1 BOX07/06/2019
1NDC:73054-101-0190 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: 3/2023
Document Id: f8104a02-dacc-bfc6-e053-6294a90a61db
Set id: 0fc8fadf-69fc-40ad-b4ca-d96dd2b30f95
Version: 7
Effective Time: 20230329
 
SOLARA SUNCARE, INC.