SOLARA SUNCARE - POUT PROTECTOR  SPF-15- zinc oxide cream 
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 - POUT PROTECTOR SPF-15 (73054-104)

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

Aqua (Water), Bisabolol, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Ethylhexanoate, Cetearyl Nonanoate, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Fructose, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Helianthus, Annuus (Sunflower) Seed Wax, Isostearic Acid, Lecithin, Mentha Spicata (Spearmint) Oil, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Portulaca Pilosa Extract (Purslane), Rubus Laciniatus (Blackberry) extract, Sorbitan Isostearate, Sorbitol/ Sebacic Acid Copolymer Behenate, Stearic Acid, Sucrose Cocoate (Stevia), Tiare Flower Extract, Tocopherol, Tribehenin , Withania Somnifera (Ashwaganda) Root Extract

OTHER INFORMATION

QUESTIONS OR COMMENTS

01b UC_Pout Protector

SOLARA SUNCARE - POUT PROTECTOR   SPF-15
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73054-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION11 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
SPEARMINT OIL (UNII: C3M81465G5)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
CETEARYL NONANOATE (UNII: F6ZWV2F361)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
FRUCTOSE (UNII: 6YSS42VSEV)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)  
RUBUS LACINIATUS WHOLE (UNII: HYX7YK7LE7)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SORBITOL (UNII: 506T60A25R)  
SEBACIC ACID (UNII: 97AN39ICTC)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73054-104-111 in 1 BOX07/06/2019
1NDC:73054-104-0110 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: f810438c-ac8e-a572-e053-6394a90a363e
Set id: ab6a326d-3b93-4122-a9f2-05e8203d31ef
Version: 6
Effective Time: 20230329
 
SOLARA SUNCARE, INC.