Label: MAUI ISLAND SECRET BROWNING CREME BROAD SPECTRUM SPF 5 SUNSCREEN- zinc oxide cream
- NDC Code(s): 82086-001-08
- Packager: Formula 7venz L.L.C.
- Category: HUMAN OTC DRUG LABEL
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
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Warnings
Skin cancer/skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown
only to prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use on damaged, or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask doctor if rash occurs.
- Directions
- Other information
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Inactive ingredients
Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, beeswax, helianthus annuus (sunflower) seed
oil, ricinus communis (castor) seed oil, glycerin, sorbitan sesquioleate, cetyl alcohol, stearyl alcohol, polyhydroxystearic acid, coffea arabica
(coffee) seed oil, camellia sinensis leaf extract, ilex paraguariensis leaf extract, rosa canina fruit oil, carthamus tinctorius (safflower) seed oil,
rubus idaeus (raspberry) fruit extract, squalane, magnesium aluminum silicate, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate,
fragrance, caramel.
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INGREDIENTS AND APPEARANCE
MAUI ISLAND SECRET BROWNING CREME BROAD SPECTRUM SPF 5 SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82086-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 7 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) YELLOW WAX (UNII: 2ZA36H0S2V) SUNFLOWER OIL (UNII: 3W1JG795YI) CASTOR OIL (UNII: D5340Y2I9G) GLYCERIN (UNII: PDC6A3C0OX) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ARABICA COFFEE OIL (UNII: IK55HKE887) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) SAFFLOWER OIL (UNII: 65UEH262IS) RASPBERRY (UNII: 4N14V5R27W) SQUALANE (UNII: GW89575KF9) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) XANTHAN GUM (UNII: TTV12P4NEE) PROPANEDIOL (UNII: 5965N8W85T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARAMEL (UNII: T9D99G2B1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82086-001-08 236 mL in 1 BOTTLE; 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)
