Label: SOLARA SUNCARE - POUT PROTECTOR SPF-15- zinc oxide cream
- NDC Code(s): 73054-104-01, 73054-104-11
- Packager: SOLARA SUNCARE, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 29, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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
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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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SOLARA SUNCARE - POUT PROTECTOR SPF-15
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73054-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 11 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73054-104-11 1 in 1 BOX 07/06/2019 1 NDC:73054-104-01 10 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/06/2019 Labeler - SOLARA SUNCARE, INC. (040998319)