SUN ESSENTIAL- octinoxate titanium dioxide lotion

Sun Essential by

Drug Labeling and Warnings

Sun Essential by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL, RODOLFO UGELSTAD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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 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.

DOSAGE & ADMINISTRATION

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 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-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

ALANINE, ALOE VERA LEAF, ARGININE, ASCORBIC ACID, ASCORBYL PALMITATE, .ALPHA.-BISABOLOL, (+/-)-,CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, CETEARYL ISONONANOATE, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCONUT, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCINE, SUNFLOWER OIL, MICA, NIACIN, OLEA EUROPAEA LEAF, PANTHENOL, PHENOXYETHANOL, LECITHIN, SOYBEAN, POTASSIUM SORBATE, SODIUM PYROPHOSPHATE, PENTYLENE GLYCOL, PROPANEDIOL, ALMOND OIL, ROSA MOSCHATA OIL, ROSEMARY, HYALURONATE SODIUM, SODIUM CITRATE, SORBITAN, TOCOPHEROL, UREA, GRAPE SEED OIL, XANTHAN GUM, WATER

PURPOSE

Sunscreen

KEEP OUT OF REACH OF CHILDREN

For external use only.
Avoid contact with eyes.
Keep out of reach of children.
Do not apply to open wounds.
STOP USE AND ask a doctor if condition worsens or
symptoms persist for more than seven days, discontinue
use of the product.

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT

Titanium Dioxide, Octinoxate

INGREDIENTS AND APPEARANCE

SUN ESSENTIAL 
octinoxate titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.5 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.20 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
ALANINE (UNII: OF5P57N2ZX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGININE (UNII: 94ZLA3W45F)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT (UNII: 3RT3536DHY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCINE (UNII: TE7660XO1C)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICA (UNII: V8A1AW0880)
NIACIN (UNII: 2679MF687A)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROPANEDIOL (UNII: 5965N8W85T)
ALMOND OIL (UNII: 66YXD4DKO9)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
ROSEMARY (UNII: IJ67X351P9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITAN (UNII: 6O92ICV9RU)
TOCOPHEROL (UNII: R0ZB2556P8)
UREA (UNII: 8W8T17847W)
GRAPE SEED OIL (UNII: 930MLC8XGG)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-009-05	30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2012

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Registrant - RODOLFO UGELSTAD (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-BOTANA INTERNATIONAL		106276728	manufacture