NATURAL SPF 50- titanium dioxide, zinc oxide lotion

Natural SPF 50 by

Drug Labeling and Warnings

Natural SPF 50 by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 7.2%

Zinc Oxide 9.5%

Purpose

Sunscreen

Warnings

Warnings When using this product

• keep out of the eye area
• rinse with water to remove
• stop use and ask a doctor if rash or irritation develops
• for external use onlyl
• keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions: for sunscreen use
● apply generously 15 minutes before sun exposure
● apply to all skin exposed to the sun
● children under 6 months of age: Ask a doctor

INDICATIONS & USAGE

Directions: for sunscreen use
● apply generously 15 minutes before sun exposure
● apply to all skin exposed to the sun
● children under 6 months of age: Ask a doctor

Inactive Ingredients

Inactive Ingredients:

carthamus tinctorius (safflower) seed oil, coconut alkanes, coco caprylate/caprate, caprylic/capric triglyceride, stearic acid, alumina, polyhydroxystearic acid, helianthus annuus (sunflower) seed oil, pongamia glabra (karanja) seed oil, vitis vinifera (grape) see oil, olea europaea (olive) oil, argania spinosa (argan) oil, oryza sativa (rice) bran extract, rosarinus officnailis (rosemary) extract, tocopherol, argania spinosa kernel oil, tocopheryl acetate (vitamin E), bisabolol, squalane

Principal Display Panel

INGREDIENTS AND APPEARANCE

NATURAL SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-8307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	780 mg  in 118 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	900 mg  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
XANTHAN GUM (UNII: TTV12P4NEE)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-8307-1	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	05/04/2017

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-8307)