Brighter By Nature™

Brighter By Nature™
SPL v1
SPL
SPL Set ID 348dbace-289c-459c-aeda-717ed3773e8d
Route
TOPICAL
Published
Effective Date 2013-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (0.0498 g) Octisalate (0.02988 g) Avobenzone (0.02689 g) Octocrylene
Inactive Ingredients
Water Butyloctyl Salicylate Methyl Trimethicone Ethyl Macadamiate Butylene Glycol Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Peg-100 Stearate Shea Butter Glyceryl Monostearate Lime Oil Citrus Maxima Fruit Rind Oil Cymbopogon Schoenanthus Oil Spearmint Oil Clary Sage Oil Pelargonium Graveolens Flower Oil Lavender Oil Thyme Oil Coriander Oil Citral Geraniol Linalool, (+/-)- .beta.-citronellol, (r)- Gentiana Lutea Root Paeonia Lactiflora Root Sanguisorba Officinalis Root Cucumber Perilla Frutescens Top Apple Scutellaria Baicalensis Root Wheat Germ Persicaria Tinctoria Top Turmeric Dulse Mangifera Indica Seed Butter Silicon Dioxide Potassium Cetyl Phosphate Cetyl Alcohol Ethylhexylglycerin Arginine Ascorbyl Glucoside Caffeine Salicylic Acid Cholesterol Docosanol Tocotrienols Linoleic Acid Hyaluronate Sodium Squalane Magnesium Ascorbyl Phosphate Palm Oil Squalene Ammonium Acryloyldimethyltaurate/vp Copolymer Caprylyl Glycol .alpha.-tocopherol Acetate Enoxolone Sodium Hydroxide Tocopherol Stearic Acid Sodium Dehydroacetate Phenoxyethanol Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-10-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active ingredients Purpose
avobenzone 3.00% Sunscreen
homosalate 5.00% Sunscreen
octisalate 5.00% Sunscreen
octocrylene 2.70% Sunscreen
Warnings

For external use only

Directions

For sunscreen use:

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 10am – 2pm
    • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor
Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water\aqua\eau • butyloctyl salicylate • methyl trimethicone • jojoba esters • polyester-8 • ethyl macadamiate • butylene glycol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • peg-100 stearate • butyrospermum parkii (shea butter) • glyceryl stearate • citrus aurantifolia (lime) oil

essential oil
, citrus grandis (grapefruit) peel oil
, cymbopogon schoenanthus oil
, mentha viridis (spearmint) leaf oil
, salvia sclarea (clary) oil
, ormenis multicaulis oil
, pelargonium graveolens flower oil
, lavandula angustifolia (lavender) oil
, thymus vulgaris (thyme) oil
, coriandrum sativum (coriander) fruit oil
, citral, geraniol, linalool, citronellol, limonene • gentiana lutea (gentian) root extract • hordeum vulgare (barley) extract\extrait d'orge • paeonia albiflora (peony) root extract • sanguisorba officinalis (burnet) root extract • cucumis sativus (cucumber) fruit extract • perilla ocymoides leaf extract • pyrus malus (apple) fruit extract • hydrolyzed rice bran extract • scutellaria baicalensis root extract • triticum vulgare (wheat) germ extract • polygonum tinctorium leaf/stem extract • curcuma longa (turmeric) root extract • palmaria palmata extract • trametes versicolor extract • micrococcus lysate • mangifera indica (mango) seed butter • silica • potassium cetyl phosphate • cetyl alcohol • ethylhexylglycerin • arginine • ascorbyl glucoside • caffeine • lecithin • phytosterols • salicylic acid • cholesterol • behenyl alcohol • tocotrienols • linoleic acid • sodium hyaluronate • squalane • magnesium ascorbyl phosphate • elaeis guineensis (palm) oil • squalene • phospholipids • ammonium acryloyldimethyltaurate/vp copolymer • caprylyl glycol • tocopheryl acetate • glycyrrhetinic acid • dehydroxanthan gum • sodium hydroxide • tocopherol • stearic acid • sodium dehydroacetate • phenoxyethanol • mica <iln38194>

Principal Display Panel 50 Ml Jar Carton

ORIGINS

Brighter By Nature SPF 35

Skin tone correcting moisturizer

Broad Spectrum SPF 35

net wt. 1.7 oz./50 ml e


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active ingredients Purpose
avobenzone 3.00% Sunscreen
homosalate 5.00% Sunscreen
octisalate 5.00% Sunscreen
octocrylene 2.70% Sunscreen
Warnings

For external use only

Directions

For sunscreen use:

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 10am – 2pm
    • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor
Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

water\aqua\eau • butyloctyl salicylate • methyl trimethicone • jojoba esters • polyester-8 • ethyl macadamiate • butylene glycol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • peg-100 stearate • butyrospermum parkii (shea butter) • glyceryl stearate • citrus aurantifolia (lime) oil

essential oil
, citrus grandis (grapefruit) peel oil
, cymbopogon schoenanthus oil
, mentha viridis (spearmint) leaf oil
, salvia sclarea (clary) oil
, ormenis multicaulis oil
, pelargonium graveolens flower oil
, lavandula angustifolia (lavender) oil
, thymus vulgaris (thyme) oil
, coriandrum sativum (coriander) fruit oil
, citral, geraniol, linalool, citronellol, limonene • gentiana lutea (gentian) root extract • hordeum vulgare (barley) extract\extrait d'orge • paeonia albiflora (peony) root extract • sanguisorba officinalis (burnet) root extract • cucumis sativus (cucumber) fruit extract • perilla ocymoides leaf extract • pyrus malus (apple) fruit extract • hydrolyzed rice bran extract • scutellaria baicalensis root extract • triticum vulgare (wheat) germ extract • polygonum tinctorium leaf/stem extract • curcuma longa (turmeric) root extract • palmaria palmata extract • trametes versicolor extract • micrococcus lysate • mangifera indica (mango) seed butter • silica • potassium cetyl phosphate • cetyl alcohol • ethylhexylglycerin • arginine • ascorbyl glucoside • caffeine • lecithin • phytosterols • salicylic acid • cholesterol • behenyl alcohol • tocotrienols • linoleic acid • sodium hyaluronate • squalane • magnesium ascorbyl phosphate • elaeis guineensis (palm) oil • squalene • phospholipids • ammonium acryloyldimethyltaurate/vp copolymer • caprylyl glycol • tocopheryl acetate • glycyrrhetinic acid • dehydroxanthan gum • sodium hydroxide • tocopherol • stearic acid • sodium dehydroacetate • phenoxyethanol • mica <iln38194>

Principal Display Panel 50 Ml Jar Carton (PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton)

ORIGINS

Brighter By Nature SPF 35

Skin tone correcting moisturizer

Broad Spectrum SPF 35

net wt. 1.7 oz./50 ml e


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)