RENEWAL FIRMING DAY BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

Renewal Firming Day by

Drug Labeling and Warnings

Renewal Firming Day by is a Otc medication manufactured, distributed, or labeled by BURT'S BEES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 2.53%

Zinc Oxide 11.9%

PURPOSE

Sunscreen

INDICATIONS & USAGE

• 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 damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if rash occurs.

Directions

• Apply gemerpis;u 15 minutes before sun exposure
• Use in the morning after cleansing
• Gently smooth over face & neck
• Children under 6 months: 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 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
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating

INACTIVE INGREDIENT

water, glycerin, caprylic/capric triglyceride, decyl oleate, isoamyl cocoate, isoamyl laurate, fragrance, cetyl alcohol, helianthus annuus (sunflower) seed oil, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-4 caprate, glyceryl stearate citrate, stearic acid, hibiscus sabdariffa flower extract, pyrus malus (apple) fruit extract, adansonia digitata fruit extract, scutellaria alpina flower/leaf/stem extract, trifolium pratense (clover) leaf extract, phragmites communis extract, poria cocos extract, beeswax, ribose, sorbitan stearate, stearyl alcohol, isostearic acid, polyhydroxystearic acid, sodium carboxymethyl C10-16 alkyl glucoside, alumina, behenyl alcohol, lesichin, polyglyceryl-3 polyricinoleate, lauryl glucoside, magnesium aluminum silicate, xanthan gum, citric acid, bisabolol, tocopherol, dipotassium glycyrrhizate, arachidyl alcohol, glycine soja (soybean) oil, sodium phytate, sodium lactate, sorbic acid, sodium PCA, sodium citrate, alcohol denat., sodium benzoate, potassium sorbate, phenoxyethanol, eugenol, limonene, linalool.

Other Information

Protect this product from excessive heat and direct sun.

QUESTIONS

(800) 849-7112 or www.burtsbees.com

PRINCIPAL DISPLAY PANEL

BURT'S BEES

RENEWAL

FIRMING

day lotion

with Hibiscus and Apple

Rejuvinating Complex

BROAD SPECTRUM SPF 30

Clinically shown to:

• Reduce look of deep wrinkles
• Help improve firmness

Net Wt. 2.0 oz / 56.7 g

INGREDIENTS AND APPEARANCE

RENEWAL FIRMING DAY  BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.53 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
YELLOW WAX (UNII: 2ZA36H0S2V)
RIBOSE, D- (UNII: 681HV46001)
ALUMINUM OXIDE (UNII: LMI26O6933)
DOCOSANOL (UNII: 9G1OE216XY)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ISOSTEARIC ACID (UNII: X33R8U0062)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DECYL OLEATE (UNII: ZGR06DO97T)
ISOAMYL COCOATE (UNII: 14OG46E98E)
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYTATE SODIUM (UNII: 88496G1ERL)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SOYBEAN OIL (UNII: 241ATL177A)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
SORBIC ACID (UNII: X045WJ989B)
ALCOHOL (UNII: 3K9958V90M)
APPLE (UNII: B423VGH5S9)
PHRAGMITES AUSTRALIS WHOLE (UNII: 8E5JPP4H6F)
FU LING (UNII: XH37TWY5O4)
CITRULLUS LANATUS VAR. LANATUS WHOLE (UNII: 3J5I6254YO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)
SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-027-02	1 in 1 BOX	01/01/2015
1	NDC: 26052-027-01	56.7 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2015

Labeler - BURT'S BEES, INC. (613480946)