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
Drug Label Information
Updated June 9, 2025
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- 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 minutes before sun exposure and as needed.
- Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
- Use water resistant sunscreen if swimming or sweating.
- Children under 6 months: ask a doctor.
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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.
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Inactive Ingredients
Aqua/Water/Eau, Glycerin, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice1, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil1, C12-15 Alkyl Benzoate, Phenoxyethanol, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Dimethicone, Lecithin, Carbomer, Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Fragrance (Parfum), Euterpe Oleracea Fruit Extract1, Aronia Melanocarpa Fruit Extract1, Lycium Barbarum Fruit Extract1, Tocopherol, Ethylhexylglycerin, Panthenol, Allantoin, Magnesium Ascorbyl Phosphate, Vitis Vinifera (Grape) Fruit Cell Extract, Rhododendron Ferrugineum Leaf Cell Culture Extract, Isomalt, Alcohol1, Aspalathus Linearis Leaf Extract1, Camellia Sinensis Leaf Extract1, Hibiscus Sabdariffa Flower Extract1.
- 1
- Certified Organic
- 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SUNFLOWER OIL (UNII: 3W1JG795YI) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) SOYBEAN LECITHIN (UNII: 1DI56QDM62) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) APPLE (UNII: B423VGH5S9) XANTHAN GUM (UNII: TTV12P4NEE) ACAI (UNII: 46AM2VJ0AW) ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) TOCOPHEROL (UNII: R0ZB2556P8) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE (UNII: ZLW3M94UYA) RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P) ISOMALT (UNII: S870P55O2W) ALCOHOL (UNII: 3K9958V90M) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) TEA LEAF (UNII: GH42T47V24) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) 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 DRUG M020 03/01/2014 Labeler - Andalou naturals (011472720) Establishment Name Address ID/FEI Business Operations Sun Deep Inc 189788201 MANUFACTURE(55560-0103)
