Label: BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11489-080-01 - Packager: BCM Ltd
- 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 December 20, 2012
If you are a consumer or patient please visit this version.
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Directions
Directions for sunscreen use
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
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
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Inactive ingredients
Aqua (Water), C12-15 alkyl benzoate, Glycerin, Dimethicone, Cetearyl olivate, Tribehenin, Butyrospermum parkii (Shea) butter, Hibiscus sabdariffa flower extract, Cetearyl alcohol, Sorbitan olivate, Alcohol denat., Prunus amygdalus dulcis (Sweet almond) oil, Sodium polyacrylate, Phenoxyethanol, Dimethicone crosspolymer, Parfum (Fragrance), Caprylyl glycol, Xanthan gum, Citric acid,
Sodium benzoate, Sodium hyaluronate, Ethylhexylglycerin, Dipropylene glycol, Tetrasodium EDTA, Potassium hydroxide, Tocopheryl acetate, Benzoic acid, Dehydroacetic acid -
Description
Formulated with hyaluronic acid to instantly boost moisture levels.
Active plant extract, Hibiscus, contains natural AHAs which mildly exfoliate to help leave skin smoother and brighter.
Directions: Use every morning after cleansing. Colour may vary due to natural ingredients. Formulated without parabens.
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INGREDIENTS AND APPEARANCE
BOTANICS HYDRATING DAY ALL BRIGHT SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11489-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.5 g in 50 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.5 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) CETEARYL OLIVATE (UNII: 58B69Q84JO) TRIBEHENIN (UNII: 8OC9U7TQZ0) SHEA BUTTER (UNII: K49155WL9Y) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SORBITAN OLIVATE (UNII: MDL271E3GR) ALMOND OIL (UNII: 66YXD4DKO9) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE SODIUM (UNII: MP1J8420LU) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BENZOIC ACID (UNII: 8SKN0B0MIM) DEHYDROACETIC ACID (UNII: 2KAG279R6R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11489-080-01 1 in 1 CARTON 1 50 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/14/2013 Labeler - BCM Ltd (230780322) Registrant - The Boots Company Plc (218622660) Establishment Name Address ID/FEI Business Operations BCM Ltd 230780322 manufacture(11489-080) , analysis(11489-080)
