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NDC 71197-0779-04 Life Extension Shade Factor SPF30 60 mg/mL Details

Life Extension Shade Factor SPF30 60 mg/mL

Life Extension Shade Factor SPF30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Quality Supplements and Vitamins, Inc.. The primary component is TITANIUM DIOXIDE.

Product Information

NDC	71197-0779
Product ID	71197-779_46761892-ada8-2370-e054-00144ff88e88
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Life Extension Shade Factor SPF30
Proprietary Name Suffix	n/a
Non-Proprietary Name	TITANIUM DIOXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	60
Active Ingredient Units	mg/mL
Substance Name	TITANIUM DIOXIDE
Labeler Name	Quality Supplements and Vitamins, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71197-0779-04 (71197077904)

Pricing Information	N/A
NDC Package Code	71197-779-04
Billing NDC	71197077904
Package	118 mL in 1 TUBE (71197-779-04)
Marketing Start Date	2017-01-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4675f287-6147-11f0-e054-00144ff88e88 Details

Drug Facts

Active ingredients

Titanium Dioxide 6%, Zinc Oxide 6%

Purpose

Sunscreen

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), descreases 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. 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

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours
use a water-.resistant sunscreen if swimming or sweating
Sun Protection Measures. Spending time in the sun increases your risk of skin .cancer and early skin aging. To decrease this risk, regularly use asunscreen with .a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m.to 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months of age: Ask a doctor

Other information

protect this product in this container from excessive heat and direct sun

Inactive ingredients

aloe juice, carrot seed extract, chamoile extract, cocoa seed butter, coconut oil, corn propanediol, cucumber fruit extract, green tea leaf extract, gluconolactone, glycerin, licorice root extract, milk thistle fruit extract, niacinamide, oat betaglucan, octyl palmitate, orange oil, rosemary extract, sodium benzoate, sodium hydroxypropylsulfonate laurylglucosides, sunflower seed oil, sweet almond oil, tocopherol (vitamin E), water, watermelon fruit extract, xanthan gum.

Questions or comments?

1-866-280-2852

Package Labeling:

INGREDIENTS AND APPEARANCE

LIFE EXTENSION SHADE FACTOR SPF30

titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71197-779
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
CHAMOMILE (UNII: FGL3685T2X)
COCONUT OIL (UNII: Q9L0O73W7L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
LICORICE (UNII: 61ZBX54883)
NIACINAMIDE (UNII: 25X51I8RD4)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ORANGE OIL (UNII: AKN3KSD11B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALMOND OIL (UNII: 66YXD4DKO9)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
WATERMELON (UNII: 231473QB6R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71197-779-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	01/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/17/2017

Labeler - Quality Supplements and Vitamins, Inc. (079557728)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source, LLC		080354456	manufacture(71197-779)

Revised: 1/2017

Document Id: 46761892-ada8-2370-e054-00144ff88e88

Set id: 4675f287-6147-11f0-e054-00144ff88e88

Version: 1

Effective Time: 20170119