Label: VEGAN COLLAGEN EVERY DAY SPF 30- avobenzone, homosalate, octocrylene, octyl salicylate lotion
- NDC Code(s): 61197-510-00
- 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 February 9, 2023
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- Official Label (Printer Friendly)
- Active ingredients Purpose
- Uses
- INDICATIONS & USAGE
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
Shake well before use. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating.
Reapply after swimming or sweating. Reapply at least every 2 hours. 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. Children under 6 months: ask a doctor. -
Inactive ingredients:
Aqua, Butyloctyl Salicylate, Coconut Alkanes, Coco-Caprylate/Caprate, Aloe Barbadensis Leaf Juice, Glycerin, Hydrolyzed Jojoba Esters, Glyceryl Stearate, Glyceryl Stearate Citrate, Sodium Stearoyl Glutamate, Polyglyceryl-4 Isostearate, Stearic Acid, Lysolecithin, Sclerotium Gum, Xanthan Gum, Pullulan, Hydrogenated Castor Oil, Sr-Hydrozoan Polypeptide-1 (Vegan Collagen), Sodium Hyaluronate, Citrus Aurantium Dulcis (Orange) Flower Extract, Jasminum Officinale (Jasmine) Extract, Chamomilla Recutita (Matricaria) Flower Extract, Arnica Montana Extract, Squalane, Oryza Sativa (Rice) Starch, Biosaccharide Gum-1, Phenoxyethanol, Ethylhexylglycerin, Parfum*.
*our scent blend with natural and/or essential oils
- Other information
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- Vegan Collagen Every Day SPF 30 Label
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INGREDIENTS AND APPEARANCE
VEGAN COLLAGEN EVERY DAY SPF 30
avobenzone, homosalate, octocrylene, octyl salicylate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-510 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) PULLULAN (UNII: 8ZQ0AYU1TT) SQUALANE (UNII: GW89575KF9) ARNICA MONTANA (UNII: O80TY208ZW) HYALURONATE SODIUM (UNII: YSE9PPT4TH) STEARIC ACID (UNII: 4ELV7Z65AP) BETASIZOFIRAN (UNII: 2X51AD1X3T) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCONUT ALKANES (UNII: 1E5KJY107T) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) ALOE VERA LEAF (UNII: ZY81Z83H0X) XANTHAN GUM (UNII: TTV12P4NEE) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) JASMINUM OFFICINALE WHOLE (UNII: X3314B4SYD) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-510-00 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/09/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/09/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Sun Deep Inc. 189788201 manufacture(61197-510)
