Solara (as Pld) -time Traveler Spf-30 Unscented (73054-105)

Solara (as Pld) -time Traveler Spf-30 Unscented (73054-105)
SPL v10
SPL
SPL Set ID f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc9
Route
TOPICAL
Published
Effective Date 2019-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
Water Medium-chain Triglycerides Glycerin C13-15 Alkane Polyglyceryl-4 Isostearate Shea Butter Coco-caprylate Propanediol Coconut Oil Hydrogenated Castor Oil Magnesium Sulfate Anhydrous Prezatide Copper Acetyl Hexapeptide-8 Ceramide Ng Helianthus Annuus Seed Wax Squalane Sunflower Oil Tocopherol Withania Somnifera Root Perilla Frutescens Leaf Punica Granatum Flower Oat Gardenia Taitensis Flower Rubus Idaeus Leaf Potassium Sorbate Kakadu Plum Polyglyceryl-3 Ricinoleate Polyhydroxystearic Acid (2300 Mw) Cetyl Palmitate Sorbitan Monopalmitate Caprylyl Glycol Phenylpropanol Sorbitan Olivate Isostearic Acid Lecithin, Sunflower Fructose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-06

Description

Non-Nano, Non-Coated Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Non-Nano, Non-Coated Zinc Oxide 20%

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
Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4

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

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
Other Information
  • Protect this product from excessive heat and direct sun.
Active Ingredients

Non-Nano, Non-Coated Zinc Oxide 20%

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, Copper Tripeptide-1, Acetyl Heptapeptide-4, Ceramide Ng, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Withania Somnifera (Ashwagandha) Root

Extract, Perilla Frutescens (Mint) Leaf Extract, Punica Granatum Flower Extract, Avena Sativa (Oat) Kernel Extract, Gardenia Taitensis (Tahitian Gardenia) Flower Extract, Rubus Idaeus Leaf Extract, Potassium Sorbate, Terminalia Ferdinandiana

Fruit Extract, Caprylyl Glycol, Phenylpropanol, Sorbitan Olivate, Isostearic Acid, Lecithin, Cetyl Palmitate, Sorbitan Palmitate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Fructose

Questions Or Comments
  • 1-855-859-1600 (9am – 5pm ET)

Structured Label Content

Uses (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
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen

Warnings (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

Directions (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
Other Information (OTHER INFORMATION)
  • Protect this product from excessive heat and direct sun.
Active Ingredients (ACTIVE INGREDIENTS)

Non-Nano, Non-Coated Zinc Oxide 20%

Inactive Ingredients (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, Copper Tripeptide-1, Acetyl Heptapeptide-4, Ceramide Ng, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Withania Somnifera (Ashwagandha) Root

Extract, Perilla Frutescens (Mint) Leaf Extract, Punica Granatum Flower Extract, Avena Sativa (Oat) Kernel Extract, Gardenia Taitensis (Tahitian Gardenia) Flower Extract, Rubus Idaeus Leaf Extract, Potassium Sorbate, Terminalia Ferdinandiana

Fruit Extract, Caprylyl Glycol, Phenylpropanol, Sorbitan Olivate, Isostearic Acid, Lecithin, Cetyl Palmitate, Sorbitan Palmitate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Fructose

Questions Or Comments (QUESTIONS OR COMMENTS)
  • 1-855-859-1600 (9am – 5pm ET)

Advanced Ingredient Data


Raw Label Data

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