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NDC 71413-0221-02 Natural Defense Primer Oil 3; 7.4; 4; 8 mg/g; mg/g; mg/g; mg/g Details

Natural Defense Primer Oil 3; 7.4; 4; 8 mg/g; mg/g; mg/g; mg/g

Natural Defense Primer Oil is a TOPICAL OIL in the HUMAN OTC DRUG category. It is labeled and distributed by Baja Fur, S.A. de C.V.. The primary component is AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	71413-0221
Product ID	71413-221_e98956a4-d06c-7616-e053-2a95a90a061f
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	Natural Defense Primer Oil
Proprietary Name Suffix	SPF
Non-Proprietary Name	Avobenzone, Octinoxate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	TOPICAL
Active Ingredient Strength	3; 7.4; 4; 8
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Baja Fur, S.A. de C.V.
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 71413-0221-02 (71413022102)

Pricing Information	N/A
NDC Package Code	71413-221-02
Billing NDC	71413022102
Package	1 BOTTLE in 1 CARTON (71413-221-02) / 30 g in 1 BOTTLE (71413-221-01)
Marketing Start Date	2022-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e98957fd-2e62-5e28-e053-2995a90a983c Details

Active ingredients

Octinoxate 4.9%

Titanium Dioxide 5%

Zinc Oxide 2.3%

Purpose

Sunscreen

Uses

Helps prevent Sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damage 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months of age: Ask a doctor

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. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Other information

Protect this product from excessive heat and direct sun

Inactive ingredients

Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Brassica Campestris/Aleurites Fordi Oil Copolymer, Tocopheryl Acetate, Fragrance/Parfum, BHT, Water/Eau, Sucrose, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Lecithin, Plankton Extract.

Questions or comments?

Call 1-800-227-0333 (USA only) or www.PhysiciansFormula.com

Package label. PDP

INGREDIENTS AND APPEARANCE

NATURAL DEFENSE PRIMER OIL SPF

avobenzone, octinoxate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71413-221
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71413-221-02	1 in 1 CARTON	01/01/2022
1	NDC:71413-221-01	30 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2022

Labeler - Baja Fur, S.A. de C.V. (821533098)

Revised: 1/2022

Document Id: e98956a4-d06c-7616-e053-2a95a90a061f

Set id: e98957fd-2e62-5e28-e053-2995a90a983c

Version: 1

Effective Time: 20220101