Active Ingredients
Octisalate 4.9%, Octocrylene 8.1%, Zinc Oxide 8%
Active Lotion
FDA Label NDC 68726-264
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cp Skin Health Group, Inc. for the product Active (NDC 68726-264). 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 - 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 Direction), 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
Stop use and ask a doctor if skin rash occurs.
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is 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
Children under 6 months: 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 borad specturm SPF value of 15 or higher and other skin protecting measures including:
- limit time in the sun, specially from 10a.m. - 2 p.m.
- weare long-sleeved shirts, pants, hats, and sunglasses
Other Information
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Acrylamide/Sodium Acryloyldimethyltaurate Copolymer
Bisabolol
Butyloctyl Salicylate
C13-14 Alkane
Caffeine
Caprylyl Methicone
Cetearyl Alcohol
Cetearyl Olivate
Cetyl Palmitate
Ethyl Ferulate
Ethylhexyl Methoxycrylene
Ethylhexylglycerin
Isohexadecane
Neopentyl Glycol Diheptanoate
Phenoxyethanol
Polyester-7
Polysorbate 80
Propanediol
Sodium Gluconate
Sorbitan Oleate
Sorbitan Olivate
Sorbitan Palmitate
Styrene/Acrylates Copolymer
Triethoxycaprylylsilane
Water
Xanthan Gum
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