RODAN AND FIELDS REDEFINE AGE SHIELD HAND SHIELD BALM SPF30- octisalate, avobenzone, homosalate, octocrylene emulsion

Rodan and Fields Redefine Age Shield Hand Shield Balm by

Drug Labeling and Warnings

Rodan and Fields Redefine Age Shield Hand Shield Balm by is a Otc medication manufactured, distributed, or labeled by Rodan and Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 3.0%

Homosalate 2.5%

Octisalate 5.0%

Octocrylene 2.7%

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

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 to the backs of hands and fingers every morning and 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply every 2 hours.
• Sun Protection Measures  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses
• Children under 6 months: Ask a doctor

Inactive Ingredients

COC-CAPRYLATE, TALC,POLYETHYLENE, OZOKERITE, CETEARYL ALCOHOL, POLYMETHYLSILSESQUIOXANE, C10-C30  CHOLESTEROL/LANOSTEROL ESTERS, ASCORBIC ACID, HDI/TREMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, ETHYLHEXYL PALMITATE, FRAGRANCE, PHENOXYETHANOL, TRIBEHENIN, HYDROGENATED POLYDECENE, SORBITAN ISOSTEARATE, PALMITOYL OLIGOPEPTIDE, DUNALIELLA SALINA EXTRACT.

Other Information    Protect this product from excessive heat and direct sun.

Questions or Comments   1-888-995-5656

Manufactured for Rodan and Fields, LLC

111 Maiden Lane,  Suite 400    San Francisco, CA 94108   Made in USA

AAHB030   80-02-0035 Please Recycle

visit rodanandfields.com  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS REDEFINE AGE SHIELD HAND SHIELD BALM  SPF30
octisalate, avobenzone, homosalate, octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.50 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.70 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE (UNII: 4828G836N6)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2240-2	1 in 1 CARTON	04/01/2013
1	NDC: 14222-2240-1	30 g in 1 CYLINDER; 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	04/01/2013	10/31/2020

Labeler - Rodan and Fields (051659584)