Label: RENEWAL FIRMING DAY BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion
- NDC Code(s): 26052-027-01, 26052-027-02
- Packager: BURT'S BEES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 18, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
-
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
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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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RENEWAL FIRMING DAY BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotionProduct 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)
