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

ACTIVE INGREDIENTS

Non-Nano, Non-Coated Zinc Oxide 20%

PURPOSE

Sunscreen

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

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

  • 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

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

  • Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS

  • 1-855-859-1600 (9am – 5pm ET)

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
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)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
SPEARMINT OIL (UNII: C3M81465G5)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
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: 1/2023
Document Id: f279dbcc-4571-6375-e053-2a95a90a1707
Set id: ab6a326d-3b93-4122-a9f2-05e8203d31ef
Version: 3
Effective Time: 20230117
 
SOLARA SUNCARE, INC.