SOLARA SUNCARE - POUT PROTECTOR

Manufacturer
SOLARA SUNCARE, INC.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:27:58

Label at a glance#

ProductSOLARA SUNCARE - POUT PROTECTOR SPF-15
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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

Dosage and administration

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 protect...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Non-Nano, Non-Coated Zinc Oxide 20%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

  • 1-855-859-1600 (9am – 5pm ET)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Pout Protector01b UC_Pout Protector

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73054-104-01SOLARA SUNCARE - POUT PROTECTORSPF-1510 mL in 1 TUBECREAM109
73054-104-11SOLARA SUNCARE - POUT PROTECTORSPF-151 in 1 BOXCREAM19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73054-10473054-104-01, 73054-104-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLARA SUNCARE - POUT PROTECTOR SPF-15ZINC OXIDESOLARA SUNCARE, INC.ab6a326d-3b93-4122-a9f2-05e8203d31ef2025-12-22WarningsExact identifier
ndc (package): 73054-104-01
ndc (package): 73054-104-11
ndc (product): 73054-104
ndc11 (package): 73054010401
ndc11 (package): 73054010411
spl id: 4690f7ee-2f52-3b32-e063-6394a90a806d
spl set id: ab6a326d-3b93-4122-a9f2-05e8203d31ef

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.