SOLARA SUNCARE - CLEAN FREAK  SPF-30 NATURALLY SCENTED- 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 NATURALLY SCENTED (73054-102)

ACTIVE INGREDIENTS

Non-Nano, Non-Coated Zinc Oxide 20%

PURPOSE

Sunscreen

USES

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, Prunus Amygdalus Dulcis (Sweet Almond) Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Avena Sativa (Oat) Kernel Extract, Gardenia Taitensis (Tahitian Gardenia) Flower Extract, Rubus Idaeus Leaf Extract, Impatiens Balsamina Flower Extract, Potassium Sorbate, Terminalia Ferdinandiana Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cocos Nucifera Fruit Extract, Cucumis Melo Cantalupensis Fruit Extract, Dianthus Caryophyllus Flower Extract, Fragaria Ananassa (Strawberry) Fruit
Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Musa Sapientum (Banana) Fruit Extract, Vanilla Planifolia Fruit Extract, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Cetyl Palmitate, Sorbitan Palmitate, Caprylyl Glycol, Phenylpropanol, Sorbitan Olivate, Isostearic Acid, Lecithin, Fructose, Benzyl Salicylate*, Amyl Cinnamal*, Hexyl Cinnamal*, Coumarin*, Linalool* (*0.004% or less, naturally occurring in plant extracts)

OTHER INFORMATION

QUESTIONS OR COMMENTS

01b UC_Clean Freak_Scented_6oz

SOLARA SUNCARE - CLEAN FREAK   SPF-30 NATURALLY SCENTED
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73054-102
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)  
ALMOND (UNII: 3Z252A2K9G)  
APRICOT (UNII: 269CJD5GZ9)  
OAT (UNII: Z6J799EAJK)  
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)  
IMPATIENS BALSAMINA FLOWER (UNII: 3169PS5TJH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
LEMON PEEL (UNII: 72O054U628)  
COCONUT JUICE (UNII: AMN6S4M09G)  
CUCUMBER (UNII: YY7C30VXJT)  
CANTALOUPE (UNII: 8QF5D5H6UH)  
DIANTHUS CARYOPHYLLUS FLOWER (UNII: B0D836E90S)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
BANANA (UNII: 4AJZ4765R9)  
VANILLA (UNII: Q74T35078H)  
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:73054-102-111 in 1 BOX07/06/2019
1NDC:73054-102-0190 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:73054-102-121 in 1 BOX07/06/2019
2NDC:73054-102-02180 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: f3d11c9e-2ed9-c7ab-e053-2a95a90afca8
Set id: 7a5644b9-4368-4e9a-aa22-b3307acf43cc
Version: 5
Effective Time: 20230203
 
SOLARA SUNCARE, INC.