SOLARA SUNCARE - POUT PROTECTOR SPF-15- zinc oxide cream

SOLARA SUNCARE - POUT PROTECTOR by

Drug Labeling and Warnings

SOLARA SUNCARE - POUT PROTECTOR by is a Otc medication manufactured, distributed, or labeled by SOLARA SUNCARE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLARA SUNCARE - POUT PROTECTOR  SPF-15
zinc oxide cream

Product 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
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 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)