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NDC 71197-0780-06 Life Extension Shade Factor SPF30 30; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL Details

Life Extension Shade Factor SPF30 30; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL

Life Extension Shade Factor SPF30 is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Quality Supplements and Vitamins, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	71197-0780
Product ID	71197-780_46762967-8243-6e21-e054-00144ff8d46c
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	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 80
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
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 71197-0780-06 (71197078006)

Pricing Information	N/A
NDC Package Code	71197-780-06
Billing NDC	71197078006
Package	177 mL in 1 BOTTLE, SPRAY (71197-780-06)
Marketing Start Date	2017-01-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 46762967-8242-6e21-e054-00144ff8d46c Details

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%

Octisalate 5%, Octocrylene 8%

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

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-resistantsunscreen 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 a sunscreen 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 leaf juice, ascorbyl palmitate (vitamin C), carrot seed extract, chamomile extract, cucumber extract, green tea leaf extract, licorice extract, milk thistle stem extract, niacinamide, oat betaglucan, parfum - natural vanilla fragrance, polysorbate 20, rosemary extract, sd alcohol 40b, sodium pca, watermelon fruit extract.

Questions or comments?

1-866-280-2852

Package Labeling:

INGREDIENTS AND APPEARANCE

LIFE EXTENSION SHADE FACTOR SPF30

avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71197-780
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
CHAMOMILE (UNII: FGL3685T2X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LICORICE (UNII: 61ZBX54883)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
WATERMELON (UNII: 231473QB6R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71197-780-06	177 mL in 1 BOTTLE, SPRAY; 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(71197-780)

Revised: 1/2017

Document Id: 46762967-8243-6e21-e054-00144ff8d46c

Set id: 46762967-8242-6e21-e054-00144ff8d46c

Version: 1

Effective Time: 20170119