FDA Label for Solar Protection Formula Spf 60 Tinted Concealer - (blush) Sunscreen
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS:
- PURPOSE
- USES:
- WARNINGS:
- OTC - DO NOT USE
- OTC - STOP USE
- OTC - WHEN USING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTHER INFORMATION:
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- PRINCIPAL DISPLAY PANEL – BEIGE CARTON LABEL
- PRINCIPAL DISPLAY PANEL – HONEY CARTON LABEL
- PRINCIPAL DISPLAY PANEL – BLUSH CARTON LABEL
Solar Protection Formula Spf 60 Tinted Concealer - (blush) Sunscreen Product Label
The following document was submitted to the FDA by the labeler of this product Fallien Cosmeceuticals, Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
DRUG FACTS
Active Ingredients:
Octinoxate 6%
Octocrylene 7%
Oxybenzone 4%
Titanium Dioxide 10%
Zinc Oxide 3.4%
Purpose
Sunscreen
Sunscreen
Sunscreen
Sunscreen
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.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
SHAKE WELL BEFORE USING
Other Information:
- Protect this product from excessive heat and direct sun
- May stain some fabrics
Directions:
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant product if swimming or sweating.
- Reapply 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients:
Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, Caramel, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Methylparaben, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
Manufactured exclusively for Fallien Ltd., West Norriton, PA Made in USA
Solar Protection Formula offers the most complete protection from UVB/UVA available, and is essential for the medically light sensitive and for those concerned with the damaging effects of the sun.
Principal Display Panel – Beige Carton Label
SOLAR
PROTECTION
FORMULA®
TINTED
CONCEALER
SPF 60
Broad Spectrum
UVA/UVB
2 Fl.Oz./59 ml
Principal Display Panel – Honey Carton Label
SOLAR
PROTECTION
FORMULA®
TINTED
CONCEALER
SPF 60
Broad Spectrum
UVA/UVB
2 Fl.Oz./59 ml
Principal Display Panel – Blush Carton Label
SOLAR
PROTECTION
FORMULA®
TINTED
CONCEALER
SPF 60
Broad Spectrum
UVA/UVB
2 Fl.Oz./59 ml
* Please review the disclaimer below.