Label: RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide lotion
- NDC Code(s): 82086-002-34
- Packager: Formula 7venz L.L.C.
- 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 July 5, 2021
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
• Apply liberally and evenly 15 minutes prior to sun exposure
• Reapply: After 40 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours
• Children under 6 months of age: 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 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
- Other information
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Inactive ingredients
Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, helianthus annuus (sunflower) seed
oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl
alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis
leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit
extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate.
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INGREDIENTS AND APPEARANCE
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82086-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 18 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SUNFLOWER OIL (UNII: 3W1JG795YI) CASTOR OIL (UNII: D5340Y2I9G) YELLOW WAX (UNII: 2ZA36H0S2V) RICE BRAN (UNII: R60QEP13IC) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SHEA BUTTER (UNII: K49155WL9Y) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SAFFLOWER OIL (UNII: 65UEH262IS) RASPBERRY (UNII: 4N14V5R27W) SQUALANE (UNII: GW89575KF9) XANTHAN GUM (UNII: TTV12P4NEE) PROPANEDIOL (UNII: 5965N8W85T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82086-002-34 100 mL in 1 TUBE; Type 0: Not a Combination Product 07/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/02/2020 Labeler - Formula 7venz L.L.C. (118069729)
