Label: FUTURE YOUTH DAILY TURNAROUND HYDRATING MOISTURIZER SPF 50- avobenzone, homosalate, octisalate, and octocrylene cream
- NDC Code(s): 61197-219-00
- Packager: Pacifica Beauty, LLC
- 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 August 17, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Indications & Usage
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Warnings
Warnings
For external use only. Do not use on damaged or broken skin. Stop use & ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Can stain clothing. Keep away from clothes. Children under 6 months: ask a doctor.
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Directions
Directions
Apply + reapply at least every 80 minutes. Sun protection measures. Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses.
- Keep Out of Reach of Children
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Inactive Ingredients
Inactive ingredients
Aqua, Butyloctyl Salicylate, Coconut Alkanes, Glycerin, Aloe Barbadensis Leaf Juice, Glyceryl Stearate, Glyceryl Stearate Citrate, Sodium Stearoyl Glutamate, Oryza Sativa (Rice) Starch, Polyglyceryl-4 Isostearate, Levulinic Acid, Sodium Levulinate, Camellia Japonica Seed Oil, Potassium Sorbate, Acetic Acid, Phenoxyethanol, Biosaccharide Gum-1, Hydrolyzed Jojoba Esters, Parfum (Natural), Lysolecithin, Sclerotium Gum, Coco-Caprylate/Caprate, Pullulan, Xanthan Gum, Ethylhexylglycerin, Fragaria Ananassa (Strawberry) Seed Oil, Niacinamide, Tocopherol, Saccharomyces/Xylinum/Black Tea Ferment, Oryz Sativa (Rice) Extract, Leuconostoc/Radish Root Ferment Filtrate, Daucus Carota Sativa (Carrot) Seed Oil, Saccharomyces/Malpighia Glabra (Acerola) Fruit Ferment Filtrate, Rosa Canina Fruit Oil, Leontopodium Alpinum Flower/Leaf Extract, Paseolus Angularis Seed Extract, Citric Acid, Paeonia Albiflora (Peony) Root Extract, Palmitoyl Tripeptide-5, Passiflora Incarnata Flower Extract, Vanilla Planifolia Fruit Extract, Acetyl Hexapeptide-8, Dextran, Sh-Polypeptide-50, Caprooyl Tetrapeptide-3, Trifluoroacetyl Tripeptide-2, Ectoin, Myristyl Nicotinate.
- Other Information
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FUTURE YOUTH DAILY TURNAROUND HYDRATING MOISTURIZER SPF 50
avobenzone, homosalate, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-219 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength COCONUT ALKANES (UNII: 1E5KJY107T) LEVULINIC ACID (UNII: RYX5QG61EI) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) ADZUKI BEAN (UNII: 31GYU1X0FP) ECTOINE (UNII: 7GXZ3858RY) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) NIACINAMIDE (UNII: 25X51I8RD4) RICE GERM (UNII: 7N2B70SFEZ) MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) CARROT SEED OIL (UNII: 595AO13F11) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) SODIUM LEVULINATE (UNII: VK44E1MQU8) CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) VANILLA (UNII: Q74T35078H) STARCH, RICE (UNII: 4DGK8B7I3S) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) ACETIC ACID (UNII: Q40Q9N063P) PHENOXYETHANOL (UNII: HIE492ZZ3T) PULLULAN (UNII: 8ZQ0AYU1TT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) STRAWBERRY SEED OIL (UNII: 9I73N69W76) LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) DEXTRAN 40 (UNII: K3R6ZDH4DU) CAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R) TRIFLUOROACETYL TRIPEPTIDE-2 (UNII: E6WT9V3SGO) MYRISTYL NICOTINATE (UNII: 8QWM6I035C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ELASTIN (HUMAN) (UNII: VRC4754D50) BETASIZOFIRAN (UNII: 2X51AD1X3T) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-219-00 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/25/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 06/25/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Sun Deep Inc. 189788201 manufacture(61197-219)
