Label: PLANET PROTECTING SUNSCREEN 30- titanium dioxide lotion
- NDC Code(s): 69555-037-30
- Packager: Stream2Sea, 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 June 25, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DIRECTIONS
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OTHER SAFETY INFORMATION
OTHER INFORMATION
- Protect this product from excessive heat and sunlight
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REEF-LEGAL SUNSCREEN TO PROTECT PALAU AND THE FUTURE OF THE PLANET
- Many sunscreens contain chemicals that damage the planet's reefs and wildlife when you wear it in the water. This one doesn't. So you can save your skin and the Earth's.
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS
Deionized Water, Aqueous Extracts of Camellia sinensis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)* and Olea Europa (Olive) Leaf*, Caprylic/Capric Triglyceride, Aloe Barbedensis (Aloe) Leaf juice*, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhydroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Cocos Nucifera (Coconut) Oil*, Stearic acid, Acrylates Copolymer, Magnesium Aluminium Silicate, Sorbitan Palmitate, Tocopherol, Xanthum Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Iron Oxides *ORGANIC INGREDIENTS
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLANET PROTECTING SUNSCREEN 30
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69555-037 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 8.8 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) HOLY BASIL LEAF (UNII: SCJ765569P) ALARIA ESCULENTA (UNII: EJ9JK8J58D) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALOE (UNII: V5VD430YW9) COCO-GLYCERIDES (UNII: ISE9I7DNUG) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SORBITAN OLIVATE (UNII: MDL271E3GR) CETEARYL OLIVATE (UNII: 58B69Q84JO) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) COCONUT OIL (UNII: Q9L0O73W7L) STEARIC ACID (UNII: 4ELV7Z65AP) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) BENZYL ALCOHOL (UNII: LKG8494WBH) SALICYLIC ACID (UNII: O414PZ4LPZ) SORBIC ACID (UNII: X045WJ989B) FERROUS OXIDE (UNII: G7036X8B5H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69555-037-30 90 mL in 1 TUBE; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/01/2022 Labeler - Stream2Sea, LLC (052920828) Establishment Name Address ID/FEI Business Operations Stream2Sea, LLC 052920828 manufacture(69555-037)
