Natural Defense Primer Oil - Baja Fur

Natural Defense Primer Oil by

Drug Labeling and Warnings

Natural Defense Primer Oil by is a Otc medication manufactured, distributed, or labeled by Baja Fur, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURAL DEFENSE PRIMER OIL SPF- avobenzone, octinoxate, octisalate, octocrylene oil 
Baja Fur, S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Natural Defense Primer Oil - Baja Fur

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

34390-5

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

Version: 1

Effective Time: 20220101