SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED- zinc oxide lotion

SOLARA SUNCARE - GLOW GETTER by

Drug Labeling and Warnings

SOLARA SUNCARE - GLOW GETTER 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

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

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, Coffea Arabica (Coffee) Seed Oil, Nelumbo Nucifera Leaf Extract, Squalane, Helianthus Annuus (Sunflower) Seed Wax, 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, Mica, Tin Oxide, Fructose, Benzyl Salicylate*, Amyl Cinnamal*, Hexyl Cinnamal*, Coumarin*, Linalool*, Titanium Dioxide (CI 77891) (*0.004% or less, naturally occurring in plant extracts)

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 - GLOW GETTER  SPF-30 NATURALLY SCENTED
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73054-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
ARABICA COFFEE OIL (UNII: IK55HKE887)
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
SQUALANE (UNII: GW89575KF9)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
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)
DIANTHUS CARYOPHYLLUS FLOWER (UNII: B0D836E90S)
CANTALOUPE (UNII: 8QF5D5H6UH)
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)
MICA (UNII: V8A1AW0880)
STANNIC OXIDE (UNII: KM7N50LOS6)
FRUCTOSE (UNII: 6YSS42VSEV)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73054-103-11	1 in 1 BOX	07/06/2019
1	NDC: 73054-103-01	90 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)