Label: TREEACTIV SAFFLOWER OLEOSOMES DAILY NATURAL MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72841-101-01 - Packager: Leiluna LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 15, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient(s)
- Purpose
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Use(s)
- 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
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Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.
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Sun Protections Measures. Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
- limiting time in the sun especially from 10:00a.m. - 2:00 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses.
Chidren under 6 months: Ask a doctor
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Inactive Ingredients
Aqua (Water), C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Polysorbate 60, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil1, Cetearyl Alcohol, Coco-Glucoside, Caprylic/Capric Triglyceride, Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Sclerotium Gum, Caprylyl Glycol, Polyhydroxystearic Acid, Phytic Acid, Xanthan Gum, Hamamelis Virginiana (Witch Hazel) Water, Citric Acid, Alcohol
- 1
- Certified organic
- Other Information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
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INGREDIENTS AND APPEARANCE
TREEACTIV SAFFLOWER OLEOSOMES DAILY NATURAL MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72841-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 130 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SAFFLOWER OIL (UNII: 65UEH262IS) POLYSORBATE 60 (UNII: CAL22UVI4M) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO GLUCOSIDE (UNII: ICS790225B) ISOSTEARIC ACID (UNII: X33R8U0062) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) BETASIZOFIRAN (UNII: 2X51AD1X3T) WITCH HAZEL (UNII: 101I4J0U34) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID ACETATE (UNII: DSO12WL7AU) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) FYTIC ACID (UNII: 7IGF0S7R8I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72841-101-01 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2019 Labeler - Leiluna LLC (080065214) Establishment Name Address ID/FEI Business Operations Island Kinetics, Inc. d.b.a. CoValence Laboratories 959735002 MANUFACTURE(72841-101)
