PLANET PROTECTING SUNSCREEN 30- titanium dioxide lotion

Planet Protecting Sunscreen 30 by

Drug Labeling and Warnings

Planet Protecting Sunscreen 30 by is a Otc medication manufactured, distributed, or labeled by Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

ACTIVE INGREDIENTS

8.8% Titanium dioxide (Non-Nano)

PURPOSE

PURPOSE
Sunscreen

INDICATIONS & USAGE

USES

• Helps prevent sunburn

WARNINGS

WARNINGS

• For external use only.
• Do not use on damaged or broken skin.
• Stop use and ask a doctor if rash occurs.
• When using this product, keep out of eyes, Rinse with water to remove.
• Keep babies and young children out of direct sunlight.

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.
• Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
• For children under 6 months of age; ask a doctor.
• Wear UPF clothing and apply to exposed skin in small amounts to start.

OTHER SAFETY INFORMATION

OTHER INFORMATION

• Protect this product from excessive heat and sunlight
• 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.

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

OUR PACKAGE IS MADE USING SUGARCANE RESIN, PLEASE RECYCLE

Manufactured in the USA by: Stream2Sea | Bowling Green, FL 33834 Questions: 866-960-9513 | Stream2Sea.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLANET PROTECTING SUNSCREEN 30+ NDC: 69555-037-30 - 3 FL OZ/90 ML - Label

INGREDIENTS AND APPEARANCE

PLANET PROTECTING SUNSCREEN 30 
titanium dioxide lotion

Product 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)