Sun Therape Face And Body Lotion
FDA Label NDC 67879-309

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmagel International Inc for the product Sun Therape Face And Body (NDC 67879-309). 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 for sunscreen use:, inactive ingredients:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone..........................3.0%

Octinoxate............................7.5%

Octisalate.............................5.0%

Oxybenzone..........................3.0%

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 warm water to remove
• Stop use and ask doctor if rash occurs

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 For Sunscreen Use:

• Apply liberally and evenly 15 minutes before sun exposure
• 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 broad spectrum SPF 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
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor

Inactive Ingredients:

WATER (AQUA), ETHYLHEXYL PALMITATE, PROPYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, DIMETHICONE, PALMITIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, STEARIC ACID, MYRISTYL MYRISTATE, CAPRYLYL GLYCOL, HYDROXYETHYLCELLULOSE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, ALLANTOIN, HEXYLENE GLYCOL, MYRISTYL LAURATE, PANTHENOL, TETRASODIUM EDTA, AMINOMETHYL PROPANOL, GLYCERIN, GLYCOLIC ACID, BUTYLENE GLYCOL, MORUS ALBA LEAF EXTRACT, CAMELLIA SINENSIS (BLACK TEA) LEAF EXTRACT, ELETTARIA CARDAMOMUM SEED EXTRACT, JASMINUM OFFICINALE FLOWER/LEAF EXTRACT, ROSE EXTRACT, MYRISTIC ACID, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE, KOJIC ACID, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, MAGNESIUM ASCORBYL PHOSPHATE, NIACIN, PERSEA GRATISSIMA (AVOCADO) OIL, PHYLLANTHUS EMBLICA FRUIT EXRACT, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, UNDECYLENOYL PHENYLALANINE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ARACHIDIC ACID, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, BHT, ABIES BALSAMEA (BALSAM CANADA) EXTRACT, CANANGA ODORATA (YLANG) FLOWER EXTRACT, COFFEA ARABICA LEAF/SEED EXTRACT, CUCUMIS MELO CANTALUPENSIS FRUIT EXTRACT, FERULA GALBANIFLUA GUM EXTRACT, HYACINTHUS ORIENTALUS (HYACINTHUS) FLOWER EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, GINKGO BILOBA LEAF EXTRACT, LIMONIUM GERBERI EXTRACT, SODIUM BENZOATE, LACTIC ACID, UNDECYLENIC ACID, POTASSIUM SORBATE, YELLOW 6 (CI 15985), LECITHIN, PLANKTON EXTRACT, CHLORPHENESIN, RED 40 (CI 16035), BENZOIC ACID, SORBIC ACID

Other Information

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

Questions Or Comments?

Call toll free 800-882-4889

* Please review the disclaimer below.