FDA.reportPublic FDA data

Instanatural Vitamin C SPF 30 Setting Spray

Manufacturer
Prime Enterprises
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:57:25

Label at a glance#

ProductInstanatural Broad Spectrum SPF 30
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE
Label structure8 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 well before use Spray liberally 15 minutes before sun exposure and rub into skin Hold container 4 to 6 inches from the skin to apply Do not spray directly into face. Spray on hands then apply to face Do not apply in windy conditions Use in a well-ventilated area Reapply: After 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in th...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5%

Homosalate 7.5%

Avobenzone 3%

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
  • Flammable: Do not use near heat, flame or while smoking. Do not store at temperatures above 120F

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it in.

Stop use and ask doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • Spray liberally 15 minutes before sun exposure and rub into skin
  • Hold container 4 to 6 inches from the skin to apply
  • Do not spray directly into face. Spray on hands then apply to face
  • Do not apply in windy conditions
  • Use in a well-ventilated area
  • Reapply:
  • After 80 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in sun, especially 10am - 2pm
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor before use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Extract, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Sinensis Leaf Extract, Centella Asiatica Leaf Extract, Fragrance, Glycerin, Hibiscus Rosa-Sinensis Flower Extract, Polyester-8, Rosmarinus Officinalis (Rosemary) Extract, SD Alcohol 40-B, Sodium Ascorbyl Phosphate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other Information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • Avoid spraying on fabrics - could cause discoloration

Instanatural Vitamin C SPF 30 Setting Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-066358443-0663-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
ALCOHOL3K9958V90MIACT
AVOBENZONEG63QQF2NOXACTIB
LEVOMENOL24WE03BX2TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTISALATE4X49Y0596WACTIB
ASCORBYL PALMITATEQN83US2B0NIACT
HOMOSALATEV06SV4M95SACTIB
GLYCERINPDC6A3C0OXIACT
VINYL ACETATEL9MK238N77IACT
DIBUTYL MALEATE4X371TMK9KIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
ROSEMARYIJ67X351P9IACT
WATER059QF0KO0RIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
HIBISCUS ROSA-SINENSIS FLOWERVB092Y7Z8TIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
ISOBORNYL ACRYLATEIX0PRH184PIACT

Source Document#

Source XML

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
1e90c9d4-192f-e06a-e063-6294a90a84341e90c9d4-192e-e06a-e063-6294a90a84342024-07-31WarningsExact identifier
spl id: 1e90c9d4-192f-e06a-e063-6294a90a8434
spl set id: 1e90c9d4-192e-e06a-e063-6294a90a8434

Reported adverse events (FAERS/openFDA)#

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