STANDARD PROCEDURE LIP BALM SPF 50- zinc oxide homosalate octocrylene stick

Standard Procedure Lip Balm SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Zinc Oxide 8%
Homosalate 6%
Octocrylene 3%

DOSAGE & ADMINISTRATION

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

Purpose

Sunscreen

Uses

Helps prevent sunbum

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

Warnings

For external use only
Do not use on damaged or broken 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 a Poison Control Center right away

Directions

Apply generously and evenly 15 minutes before sun exposure reapply at least every 80 minutes 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, regularty use a sunscreen with broad spectrum SPF 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

Other Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Caprylic/capric Triglyceride, Ozokerite, C12-15 Alkyl| Benzoate, Butyrospermum Parki (Shea) Butter, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Tribehenin, Silica Dimethyl Silylate, Polyglyceryl-3 Polyricinoleate, Bis-Ethythexyloxyphenol Methoxypheny! Triazine, Flavor, Triacontanyl Pup,Tocopheryl Acetate, Stevia Rebaudiana Leaf

Package Label. Principal Display Panel

Standard Procedure

Lipbalm SPF 50+

Coconut

Broad Spectrum UVA/UVB

5g 0.17oz.

IMAGE Lip Balm 240410.jpg

INGREDIENTS AND APPEARANCE

STANDARD PROCEDURE LIP BALM SPF 50 
zinc oxide homosalate octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84425-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	60 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
BEMOTRIZINOL (UNII: PWZ1720CBH)
METHYL SALICYLATE (UNII: LAV5U5022Y)
STEVIA REBAUDIANA LEAF (UNII: 6TC6NN0876)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
CERESIN (UNII: Q1LS2UJO3A)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84425-105-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/22/2024

Labeler - Standard Procedure Inc (119276141)