Active Ingredients
Avobenzone 3%
Homosalate 5%
Octisalate 5%
Tanning Sunscreen Spf 15 Aerosol, Spray
FDA Label NDC 75712-139
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Tanning Sunscreen Spf 15 (NDC 75712-139). 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, do not use, when using this product, stop use and ask a doctor if, 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
- 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.
Do Not Use
- on damaged or broken skin
When Using This Product
- keep out of eyes. Rinse with water to remove.
- do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F.
Stop Use And Ask A Doctor If
- rash occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally 15 minutes before sun exposure
- 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-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: Ask a doctor
Other Information
- protect the product from excessive heat and direct sun
- avoid long term storage above 40°C (104°F)
Inactive Ingredients
alcohol denat., diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate
Disclaimers
May stain or damage some fabrics or surfaces
*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ® Sunscreen Spray Tanning Broad Spectrum SPF 15.
Adverse Reactions
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
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(888) 309-9030
Principal Display Panel
STUDIO SELECTION ®
SUN
TANNING
SUNSCREEN SPRAY
BROAD SPECTRUM SPF 15
Compare to Coppertone ® Sunscreen Spray Tanning Broad Spectrum SPF 15*
- Water-Resistant (80 minutes)
- Moisturizes skin
SPF 15
Non-greasy
Lightweight Feel
NET WT 5.5 OZ (156 g)
Mm01 (Mm01)
* Please review the disclaimer below.
