Label: 1000 ROSES DAILY SHADE FACIAL SPF 18- octisalate, octocrylene, and avobenzone lotion
- NDC Code(s): 55560-0103-1
- Packager: Andalou naturals
- 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 July 15, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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.
- Warnings
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Directions
- Daily, alone or under make-up.
- Apply liberally 15-30 minutes before sun exposure and as needed.
- Reapply at least every 2 hours.
- Use 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
- Children under 6 months: ask a doctor.
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Inactive Ingredients
Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Vegetable Glycerin, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil1, Plant Stem Cells (Alpine Rose, Malus Domestica, Solar Vitis) and BioActive 8 Berry Complex1, Dimethicone, Lecithin, Tocopherol, Soothing Complex: [Sodium Hyaluronate, Magnolia Officinalis Bark Extract, Boswellia Serrata (Boswellin) Extract], Panthenol, Allantoin, Rosa Damascena (Rose) Flower Distillate1, Magnesium Ascorbyl Phosphate (Vitamin C), Chamomilla Recutita (Chamomile) Flower Extract1, Calendula Officinalis Flower Extract1, Rosa Canina (Rosehip) Fruit Oil1, Punica Granatum (Pomegranate) Seed Oil1, Camellia Sinensis (White Tea) Leaf Extract12, Aspalathus Linearis (Rooibos) Extract12, Hibiscus Sabdariffa Flower Extract12, Phenethyl Alcohol, Ethylhexylglycerin, Rose Isolates, Vanilla Isolates, Pelargonium Graveolens (Rose Geranium) Flower Oil1, Citrus Aurantium Dulcis (Orange) Peel Oil1
- Other Information
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton
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INGREDIENTS AND APPEARANCE
1000 ROSES DAILY SHADE FACIAL SPF 18
octisalate, octocrylene, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55560-0103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSA RUGOSA FLOWER (UNII: 969IQC5YJU) APPLE (UNII: B423VGH5S9) VITIS VINIFERA SEED (UNII: C34U15ICXA) ACAI (UNII: 46AM2VJ0AW) ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ) ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU) EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) DIMETHICONE (UNII: 92RU3N3Y1O) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) TOCOPHEROL (UNII: R0ZB2556P8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) ROSA X DAMASCENA FLOWER (UNII: JWB78P295A) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) CHAMOMILE (UNII: FGL3685T2X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) WHITE TEA (UNII: O0M3396E09) ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GERANIOL (UNII: L837108USY) VANILLIN (UNII: CHI530446X) GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55560-0103-1 1 in 1 CARTON 03/01/2014 1 80 mL in 1 TUBE; 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 03/01/2014 Labeler - Andalou naturals (011472720) Establishment Name Address ID/FEI Business Operations Sun Deep Inc 189788201 MANUFACTURE(55560-0103)