Active Ingredients
AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 2%, OCTOCRYLENE 10%
Sun Bum Amazon 8 Oz Spf 50 Lotion
FDA Label NDC 69039-840
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sun Bum for the product Sun Bum Amazon 8 Oz Spf 50 (NDC 69039-840). 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, directions, other information, inactive ingredients, questions?, 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.
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
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 immediately.
Keep Out Of Reach Of Children
Directions
• shake well before use
• apply liberally 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
• children under 6 months of age: ask a doctor
• 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
• shake well before use
• apply liberally 15 minutes before sun exposure
Other Information
protect this product from excessive heat and direct sun
Inactive Ingredients
water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone
Questions?
1-877-978-6286
Primary Artwork Sun Bum Amazon 8 Oz Spf 15
Primary Artwork (Sb Og 8 Oz Tube Spf 15 Lotion Amazon R9 Production)
Primary Artwork Sun Bum Amazon 8 Oz Spf 30
Primary Artwork (Ai Text Sb Og 8 Oz Tube Spf 30 Lotion Amazon R10 Production)
Primary Artwork Sun Bum Amazon 8 Oz Spf 50
Primary Artwork (Sb Og 8 Oz Tube Spf 50 Lotion Amazon R9 Production)
Primary Artwork Sun Bum Amazon 8 Oz Spf 70
Primary Artwork (Ai Text Sb Og 8 Oz Tube Spf 70 Lotion Amazon R11 Production)
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