Active Ingredients
Homosalate 10%
Octocrylene 8%
Octisalate 5%
Avobenzone 3%
Standard Procedure Spf 50 Sunscreen Lotion
FDA Label NDC 84425-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Standard Procedure Inc for the product Standard Procedure Spf 50 Sunscreen (NDC 84425-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
+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
* Please review the disclaimer below.
