Solara (as Pld) - Pout Protector Spf-15 (73054-104)

Solara (as Pld) - Pout Protector Spf-15 (73054-104)
SPL v9
SPL
SPL Set ID ab6a326d-3b93-4122-a9f2-05e8203d31ef
Route
TOPICAL
Published
Effective Date 2019-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (11 g)
Inactive Ingredients
Isostearic Acid Lecithin, Sunflower Spearmint Oil Palmitoyl Tripeptide-1 Palmitoyl Lysyldioxymethionyllysine Water .alpha.-bisabolol, (+/-)- Bis-diglyceryl Polyacyladipate-2 Shea Butter Medium-chain Triglycerides Cetearyl Ethylhexanoate Cetearyl Nonanoate Coconut Oil Ethylhexyl Palmitate Fructose Glycerin Sunflower Oil Helianthus Annuus Seed Wax Polyglyceryl-3 Ricinoleate Polyhydroxystearic Acid (2300 Mw) Portulaca Pilosa Whole Rubus Laciniatus Whole Sorbitan Isostearate Sorbitol Sebacic Acid Behenic Acid Stearic Acid Sucrose Cocoate Gardenia Taitensis Flower Tocopherol Tribehenin Withania Somnifera Root

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

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

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)

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

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

Advanced Ingredient Data


Raw Label Data

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