Label: MOISTURIZING LIP BALMSPF30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick
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Contains inactivated NDC Code(s)
NDC Code(s): 62111-0211-3 - Packager: AKG Innovations LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 13, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
■Apply liberally and evenly 15 minutes before sun exposure.
■Reapply at least every two hours.
■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 AM – 2 PM
• wear long sleeve shirts, pants, hats, and sunglasses
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Inactive ingredients
Beeswax, Persea Gratissima
(Avocado) Oil, Butyrospermum Parkii (Shea)
Butter, Hydrogenated Vegetable Oil, Acacia
Decurrens/Jojoba/Sunflower Seed Wax Polyglyceryl-3
Esters, Menthyl Lactate, Argania Spinosa Kernel
Oil, Tocopheryl Acetate, Dimethicone, Helianthus
Annuus (Sunflower) Seed Oil Unsaponifiables, Aloe
Barbadensis Flower Extract, Bisabolol, Curcuma
Longa (Turmeric) Root Extract, Lawsonia Inermis
(Henna) Flower/Fruit/Leaf Extract, Melia Azadirachta
Flower Extract, Melia Azadirachta Leaf Extract,
Ocimum Basilicum (Basil) Flower/Leaf Extract,
Ocimum Sanctum Leaf Extract, Coccinia Indica
Fruit Extract, Corallina Officinalis Extract, Amino
Esters-1, Citrus Aurantium Dulcis (Orange) Peel Oil,
Simmondsia Chinensis (Jojoba) Seed Oil, Retinyl
Palmitate, Palmitoyl Oligopeptide, Ethylhexyl
Palmitate, Tribehenin, Sorbitan Isostearate, Menthol,
Caprylyl Glycol, Phenoxyethanol, Chlorphenesin.
- Other information
- Questions or comments visit:
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MOISTURIZING LIP BALM SUNSCREEN BROAD SPECTRUM SPF-30 (62111-0211-3)
advanced dental health - beauty
ARTHUR GLOSMAN DDS
Beverly Hills
MOISTURIZING
LIP BALM
SUNSCREEN
BROAD
SPECTRUM
SPF-30
Net Wt. 0.15 oz. / 4.3 g
Distributed by:
AKG Innovations, LLC
450 N. Roxbury Drive,
Suite 222,
Beverly Hills, CA
90210
Made in USA
#90213
MOISTURIZING
LIP BALM
SPF-30
BROAD SPECTRUM
SUNSCREEN
Ice blue stick glides on smoothly,
leaving a soft sheen on the lips.
Cools with Menthol; moisturizes
with Avocado Oil, Shea Butter and
Jojoba Seed Oil; calms and soothes
with Dimethicone. UVA/UVB
SPF 30 protection to help prevent
sunburned lips. Can be used as
often as necessary on the lips and
around the lip area.
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INGREDIENTS AND APPEARANCE
MOISTURIZING LIP BALMSPF30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62111-0211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 80 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 22.0 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) AVOCADO OIL (UNII: 6VNO72PFC1) SHEA BUTTER (UNII: K49155WL9Y) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) SUNFLOWER OIL (UNII: 3W1JG795YI) ALOE VERA FLOWER (UNII: 575DY8C1ER) LEVOMENOL (UNII: 24WE03BX2T) CURCUMA LONGA LEAF (UNII: H2HC4RY52C) LAWSONIA INERMIS FLOWERING TOP (UNII: UF2093XE64) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) OCIMUM TENUIFLORUM TOP (UNII: 34T63W8ULS) COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5) CORALLINA OFFICINALIS (UNII: 4004498D06) CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP) JOJOBA OIL (UNII: 724GKU717M) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) ETHYLHEXYL PALMITATE (UNII: 2865993309) TRIBEHENIN (UNII: 8OC9U7TQZ0) Sorbitan Isostearate (UNII: 01S2G2C1E4) MENTHOL (UNII: L7T10EIP3A) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62111-0211-3 1 in 1 BOX 1 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/06/2014 Labeler - AKG Innovations LLC (056576137) Establishment Name Address ID/FEI Business Operations Englewood Labs LLC 172198223 manufacture(62111-0211)