STANDARD PROCEDURE SPF 50 SUNSCREEN- homosalate, octocrylene, octisalate, avobenzone lotion

Standard Procedure SPF 50 Sunscreen by

Drug Labeling and Warnings

Standard Procedure SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Standard Procedure Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 10%

Octocrylene 8%

Octisalate 5%

Avobenzone 3%

Purpose

Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only
• Do not use on damaged orbroken skin
• Stop use and ask a doctor if rash occurs
• When using this product keep out of eyes
• Rinse with water to remove

Keep out of reach of children

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

Directions

• Apply generously and evenly 15 minutes before sun exposure
• Reapply at least every 80 minutes
• Usa a water resistant sunscreen if swimming or sweating
• Sun Protection Measures.
  Speading time in the sun increases your risk of skin cancer and early skin aging. To decres this risk, regularly usa a sunscreen with broad spectum SPF of 15 or higher and other sun protection measures including:
  Limit time in thee 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 the product in this container from exessive heat and direct sun

Inactive Ingredients

BEESWAX, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, ISOPROPYL PALMITATE, CYCLOHEXASILOXANE, CETEARETH-20, ALOE BARBADENSIS LEAF JUICE, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, BENZYL ALCOHOL, CARBOMER, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRIC ACID, GLYCERIN, HYDROXYACETOPHENONE, MALTODEXTRIN, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, SODIUM STEAROYL GLUTAMATE, TOCOPHERYL ACETATE, TRIETHANOLAMINE, PHENOXYETHANOL, WATER

Contact

Standard Procedure Inc

2801 Ocean Park Blvd Unit #2062

Santa Monica CA 90405 USA

usa@standardprocedure.co

+1 213-681-1801

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Standard Procedure.

SPF 50+ Sunscreen

Australian Made

Broad Spectrum UVA/UVB Rays

80 minutes Water Resistant

INGREDIENTS AND APPEARANCE

STANDARD PROCEDURE SPF 50 SUNSCREEN 
homosalate, octocrylene, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84425-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MANGO (UNII: I629I3NR86)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PAPAYA (UNII: KU94FIY6JB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84425-101-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2024
2	NDC: 84425-101-03	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2024
3	NDC: 84425-101-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/15/2024

Labeler - Standard Procedure Inc (119276141)