Label: GREEN TEA ANTIOXIDANT BROAD SPECTRUM SPF 30 PAPLUSPLUSPLUS- oxybenzone, octisalate, and avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65903-330-01 - Packager: H2O Plus LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 26, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
- Warnings
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Directions
- For Sunscreen use
- Apply liberally 15 minutes before sun exposure
- Use water resistance sunscreen 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 broad spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun especially from 10 am-2 pm
- Wear long-sleeved shirts, pants, and sunglasses
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Inactive Ingredients
Aqua/Water/Eau, Ethylhexyl Isononanoate, Butylene Glycol, Glyceryl Stearate, C12-15 Alkyl Benzoate, Pentylene Glycol, Triisononanoin, Diethylhexyl 2,6-Naphthalate, Cera Alba/ Beeswax/Cire d'abeille, Sodium Dihydroxycetyl Phosphate, Polyglyceryl-3 Caprate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Camellia Sinensis Leaf Extract, Faex/Yeast Extract/Extrait de levure, Fucus Vesiculosus Extract, Ilex Paraguariensis Leaf Extract, Panax Ginseng Root Extract, Tilia Cordata Wood Extract, Magnesium Ascorbyl Phosphate, Tocopherol, Biotin, Calcium Pantothenate, Carbomer, Citric Acid, Disodium EDTA, Glycerin, Glycogen, Hydrogenated Palm Glycerides, Hydrolyzed Wheat Protein, Lecithin, Mannitol, Maris Sal/Sea Salt/Sel Marin, Propylene Glycol, Thermus Thermophillus Ferment, Triethanolamine, Xanthan Gum, Chlorphenesin, Methylparaben, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate (090-00330-002)
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 38 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
GREEN TEA ANTIOXIDANT BROAD SPECTRUM SPF 30 PAPLUSPLUSPLUS
oxybenzone, octisalate, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65903-330 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 60 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) Butylene Glycol (UNII: 3XUS85K0RA) Glyceryl Monostearate (UNII: 230OU9XXE4) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Pentylene Glycol (UNII: 50C1307PZG) Triisononanoin (UNII: XF4K22WN6T) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) Yellow Wax (UNII: 2ZA36H0S2V) Sodium Dihydroxycetyl Phosphate (UNII: YWI33EV595) Tilia Cordata Wood (UNII: 674MYE89IE) Horse Chestnut (UNII: 3C18L6RJAZ) Green Tea Leaf (UNII: W2ZU1RY8B0) Yeast (UNII: 3NY3SM6B8U) Fucus Vesiculosus (UNII: 535G2ABX9M) Ilex Paraguariensis Leaf (UNII: 1Q953B4O4F) Asian Ginseng (UNII: CUQ3A77YXI) Magnesium Ascorbyl Phosphate (UNII: 0R822556M5) Tocopherol (UNII: R0ZB2556P8) Biotin (UNII: 6SO6U10H04) Calcium Pantothenate (UNII: 568ET80C3D) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Citric Acid Monohydrate (UNII: 2968PHW8QP) Edetate Disodium (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Glycogen (UNII: 309GSC92U1) Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Mannitol (UNII: 3OWL53L36A) Sea Salt (UNII: 87GE52P74G) Propylene Glycol (UNII: 6DC9Q167V3) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) Trolamine (UNII: 9O3K93S3TK) Xanthan Gum (UNII: TTV12P4NEE) Chlorphenesin (UNII: I670DAL4SZ) Methylparaben (UNII: A2I8C7HI9T) Phenoxyethanol (UNII: HIE492ZZ3T) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Benzoate (UNII: OJ245FE5EU) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65903-330-01 1 in 1 CARTON 1 38 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/01/2014 Labeler - H2O Plus LLC (807722947)
