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

Standard Procedure SPF 50 Sunscreen Face and Body by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone3%, Homosalate 10%, Octisalate 5%, Octocrylene 8% Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

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.

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly
• Reapply
• after 80 minutes of swimming
• Immediately after towel drying
• at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 broad spectrum SPF 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. to 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients

Water, Beeswax, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Citric Acid.

OTHER SAFETY INFORMATION

Other information

• protect the product in this container from excessive heat and direct sun

QUESTIONS

Questions?

1 213-681-1801 or usa@standardprocedure.co

PRINCIPAL DISPLAY PANEL

Standard Procedure

SPF 50+ sunscreen

For face and body

Broad Spectrum UVA/UVB

80 Minutes Water Resistant

Added Australian Superfruits with Antioxidants and Vitamins A, B + C

INGREDIENTS AND APPEARANCE

STANDARD PROCEDURE SPF 50 SUNSCREEN FACE AND BODY 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PAPAYA (UNII: KU94FIY6JB)
BEESWAX (UNII: 2ZA36H0S2V)
CETEARETH-20 (UNII: YRC528SWUY)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
CARBOMER (UNII: 0A5MM307FC)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CITRIC ACID (UNII: 2968PHW8QP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
MANGO (UNII: I629I3NR86)
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PINEAPPLE (UNII: 2A88ZO081O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70157-027-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2025
2	NDC: 70157-027-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2025
3	NDC: 70157-027-03	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2025
4	NDC: 70157-027-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/30/2025

Labeler - Baxter Laboratories (740537709)