OCEAN FRIENDLY SUNSCREEN SPF30 BROAD SPECTRUM- titanium dioxide, zinc oxide lotion

Ocean Friendly Sunscreen SPF30 Broad Spectrum by

Drug Labeling and Warnings

Ocean Friendly Sunscreen SPF30 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Lemongrass Spa Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide (6.0%)
Zinc Oxide (6.0%)

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures. decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure

re-apply:

          after 40 minutes of swimming or sweating

          immediately after towel drying

          at least every 2 hours

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 15 or higher and other sun protection measures including:

          limit time in the sun, especially from 10 a.m. - 2 p.m.

          wear long-sleeve shirts, pants, hats and sunglasses

          children under 6 months: Ask a doctor

Inactive Ingredients

Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Glucoside, Cetearly Olivate, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Wax, Lecithin, Simmondsia Chinensis (Jojoba) Oil, Sorbitan Olivate, Tocopherol (Vitamin E), Xanthan Gum

Other Information

Protect this product from excessive heat and direct sun.

Package Labeling:

INGREDIENTS AND APPEARANCE

OCEAN FRIENDLY SUNSCREEN SPF30 BROAD SPECTRUM 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70553-731
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCONUT (UNII: 3RT3536DHY)
EUCALYPTUS GUM (UNII: 72T9EZC2VX)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70553-731-01	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/07/2017
2	NDC: 70553-731-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/15/2016

Labeler - Lemongrass Spa Products LLC (069703885)