Instanatural Vitamin C Broad Spectrum SPF 50 Lotion

Instanatural by

Drug Labeling and Warnings

Instanatural by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTANATURAL BROAD SPECTRUM SPF 50- octisalate, octocrylene, homosalate, avobenzone lotion 
Prime Enterprises

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Instanatural Vitamin C Broad Spectrum SPF 50 Lotion

Active Ingredients

Octisalate 5%

Octocrylene 5%

Homosalate 10%

Avobenzone 3%

Purpose

Sunscreen

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

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 doctor

if rash occurs

Keep out of reach of children

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

Directions

• Apply liberally 15 minutes before sun exposure
• 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Extract, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Carbomer, Centella Asiatica Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glycerin, Hibiscus Rosa-Sinensis Flower Extract, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments

CS@instanatural.com

Instanatural Vitamin C SPF 50 Broad Spectrum Lotion

INSTANATURAL  BROAD SPECTRUM SPF 50
octisalate, octocrylene, homosalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0662
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	98 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
HYPROMELLOSES (UNII: 3NXW29V3WO)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER 980 (UNII: 4Q93RCW27E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
COCOA BUTTER (UNII: 512OYT1CRR)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%) (UNII: YY2HMJ9NZF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HIBISCUS ROSA-SINENSIS FLOWER (UNII: VB092Y7Z8T)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ROSEMARY (UNII: IJ67X351P9)
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0662-4	147 mL in 1 TUBE; Type 0: Not a Combination Product	07/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/31/2024

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	analysis(58443-0662) , label(58443-0662) , manufacture(58443-0662) , pack(58443-0662)

Revised: 7/2024

Document Id: 1e906286-f835-d18d-e063-6394a90a656f

34390-5

Set id: 1e906286-f834-d18d-e063-6394a90a656f

Version: 1

Effective Time: 20240731