Active Ingredients
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%
Sun Shades Sunscreen Spray
FDA Label NDC 54473-404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca Inc. for the product Sun Shades Sunscreen (NDC 54473-404). 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, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
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
Flammable: do not use near heat, flame, or while smoking
Otc - Do Not Use
Do not use on damaged or broken skin
Do not use on damaged or broken skin
Otc - When Using
When using this product
- keep out of eyes. Rinse with water to remove.
- keep away from face to avoid breathing it
- do not puncture or incinerate. Contents under pressure.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - 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.
Dosage & Administration
Directions
- shake well before using
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- hold container 4 to 6 inches from skin to apply
- do not spray directly into face. Spray on hands, then apply to face.
- do not apply in windy conditions
- use a well-ventilated area
- 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 value 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 of age: ask a doctor
Other Safety Information
Other information
- may stain some fabrics
- protect this product from excessive heat and direct sun
- do not store at temperatures below 32 F (0 C) or above 120 F (49 C)
Inactive Ingredient
acrylates/octylacrylamide copolymer, alcohol denat, aloe barbadensis leaf juice, butylene glycol, diisopropyl adipate, fragrance (parfum), neopentyl glycol diheptanoate, simmondsia chinensis (jojoba) extract
* Please review the disclaimer below.
