Label: SEA AND C SHEER FACE SERUM- avobenzone, homosalate, octisalate, octocrylene liquid
- NDC Code(s): 61197-216-00
- 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 3, 2023
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- Active ingredients
- Uses
- INDICATIONS & USAGE
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
Shake well. Apply liberally 15 minutes before sun exposure. Use 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.
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Inactive ingredients:
Aqua, Butyloctyl Salicylate, Coconut Alkanes, Calcium Sodium Borosilicate, Cetearyl Alcohol, Parfum (Natural), Propanediol, Ascorbate (Vitamin C), Tocopherol (Vitamin E), Ascophyllum Nodosum (Kelp) Extract, Algae Extract, Withania Somnifera (Ashwagandha) Root Extract, Aloe Barbadensis Leaf Juice, Caffeine, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Coco Caprylate/ Caprate, Coco-Glucoside, Ethyl Ferulate, Fructose, Glycerin, Glyceryl Stearate, Lauroyl Lysine, Microcrystalline Cellulose, Sodium Gluconate, Sodium Stearoyl Glutamate, Xanthan Gum.
- Other information
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- Sea and C Sheer Face Serum SPF 55 Label
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INGREDIENTS AND APPEARANCE
SEA AND C SHEER FACE SERUM
avobenzone, homosalate, octisalate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-216 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) GLYCERIN (UNII: PDC6A3C0OX) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) FRUCTOSE (UNII: 6YSS42VSEV) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) LAUROYL LYSINE (UNII: 113171Q70B) SODIUM GLUCONATE (UNII: R6Q3791S76) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCONUT ALKANES (UNII: 1E5KJY107T) TOCOPHEROL (UNII: R0ZB2556P8) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) FUCUS VESICULOSUS (UNII: 535G2ABX9M) WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) COCO GLUCOSIDE (UNII: ICS790225B) ETHYL FERULATE (UNII: 5B8915UELW) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) CAFFEINE (UNII: 3G6A5W338E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PROPANEDIOL (UNII: 5965N8W85T) CALCIUM ASCORBATE (UNII: 183E4W213W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-216-00 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/03/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/03/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Bell International Laboratories, Incorporated 967781555 manufacture(61197-216)
