Label: SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED- zinc oxide lotion
- NDC Code(s): 73054-103-01, 73054-103-11
- 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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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- 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
-
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
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED
zinc oxide lotionProduct 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)
